Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity
Updated Mar 23184 units (28 US, 156 OUS) units
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with th…
Hazard. The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number…
B Braun Medical
Updated Mar 192,653,711 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number…
B Braun Medical
Updated Mar 191,174,271 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number…
B Braun Medical
Updated Mar 193,158,104 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number…
B Braun Medical
Updated Mar 19328,640 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slo…
Hazard. Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant pati…
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit…
Magellan Diagnostics
Updated Mar 13197893 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into …
Hazard. Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is…
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600…
Siemens Medical Solutions USA
Updated Mar 10U.S. 758, OUS 2077 units
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the rep…
Hazard. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6480,000 units
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F…
Angiodynamics
Updated Mar 3500 units (100 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH…
Angiodynamics
Updated Mar 34840 units (484 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH…
Angiodynamics
Updated Mar 31520 units (304 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH…
Angiodynamics
Updated Mar 31550 units (155 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH…
Angiodynamics
Updated Mar 35155 units (1031 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F…
Angiodynamics
Updated Mar 3515 units (103 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 3615 units (123 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB…
Angiodynamics
Updated Mar 31030 units (206 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…
Angiodynamics
Updated Mar 34925 units (985 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 27149439 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 271752096 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…
Medline Industries, LP
Updated Feb 272630369 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/…
Medline Industries, LP
Updated Feb 27192690 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…
Stryker Sustainability Solutions
Updated Mar 1256,740 cuffs units
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintai…
Hazard. Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 3210 units (42 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM…
Angiodynamics
Updated Mar 3320 units (64 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035…
Angiodynamics
Updated Mar 3220 units (44 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH…
Angiodynamics
Updated Mar 3450 units (45 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH…
Angiodynamics
Updated Mar 3950 units (95 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism…
Hazard. Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2779843 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2717902 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products
Updated Feb 1726900 units units
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of t…
Hazard. Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment …
Hazard. Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflamm…
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment …
Hazard. Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflamm…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. Wh…
Hazard. In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to…
Hazard. Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,848 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,884 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Mar 191,033 units units
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determine…
Hazard. Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for…
Brahms
Updated Mar 125,254 units
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which requi…
Hazard. Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ra…
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH…
Angiodynamics
Updated Mar 380 units (16 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Spacelabs Healthcare
Updated Feb 271790 units
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulti…
Hazard. Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 272154 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 271698 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 273120 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 272980 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit…
THERAKOS DEVELOPMENT
Updated May 165826 units
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl…
Hazard. Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within…
Foundation Medicine
Updated Mar 2410 units units
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT soft…
Hazard. Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is…
Magellan Diagnostics
Updated Mar 13284 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is…
Magellan Diagnostics
Updated Mar 13136 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variati…
Hazard. During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Windstone Medical Packaging
Updated Mar 11475 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Windstone Medical Packaging
Updated Mar 11520 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging
Updated Mar 11380 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Updated Mar 10119 units units
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in t…
Hazard. An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
Philips Spectral CT on Rails. Model Number: 728334.
PHILIPS MEDICAL SYSTEMS
Updated Mar 73 systems units
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at …
Hazard. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area …
The product is a handheld ultraviolet-C germicidal wand and contains a combination of…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6334 units
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No…
Tornier
Updated Mar 5233 units
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and ar…
Hazard. Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Civ Medical Instruments
Updated Mar 26 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Civ Medical Instruments
Updated Mar 25 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Civ Medical Instruments
Updated Mar 218 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Civ Medical Instruments
Updated Mar 221 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Civ Medical Instruments
Updated Mar 220 units units
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle t…
Hazard. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/servic…
Hazard. Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27594 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2782 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27240 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27966 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27108 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2720 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 2760 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27439 kits units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…
Medline Industries, LP
Updated Feb 27762 units units
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during us…
Hazard. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Synthes (USA) Products
Updated Feb 2577 units units
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones…
Hazard. A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and un…
Hazard. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevat…
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interf…
Hazard. it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Ris…