Class I - Dangerous
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Class I - Dangerous
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
TourniKwik Tourniquet Set (CFN 79012)
Medtronic Perfusion Systems
Class I - Dangerous
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Class I - Dangerous
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Class I - Dangerous
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Class I - Dangerous
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
Class I - Dangerous
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
Securitas Healthcare
Class I - Dangerous
There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and premature depletion of the battery.
Class I - Dangerous
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Beckman Coulter
Class I - Dangerous
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
Class I - Dangerous
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter
Class I - Dangerous
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
Class I - Dangerous
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Class I - Dangerous
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Securitas Healthcare
Class I - Dangerous
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
Potential for false negative response on the NIM Vital Nerve Monitoring System
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
Olympus Corporation of the Americas
Class I - Dangerous
Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Randox Laboratories
Class I - Dangerous
Cystatin C Reagent marketed without a 510 (k)