🏥 Medical Devices • 15,809 recalls
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Integra LifeSciences
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Merit Medical Systems
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Cadwell Industries
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Tornier S.A.S.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Olympus Corporation of the Americas
Potential for distal end of the sheath to break off during a procedure.
YAMAHA MOTOR
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Some applicator tips from these lots had open seals.
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Philips North America
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Maquet Medical Systems USA
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Medtronic Perfusion Systems
Potential for unsealed sterile packing.
Medtronic Perfusion Systems
Potential for unsealed sterile packing.
Philips North America
Event Catalog information does not save when copied and transferred from one unit to another.
Medtronic Perfusion Systems
Potential for unsealed sterile packing.