🏥 Medical Devices • 15,809 recalls
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Device does not mate as intended.
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
Siemens Medical Solutions USA
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
Stryker Instruments Div. of Stryker
Potential for the device cannula to overthrow past the intended length.
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Philips Medical Systems (Cleveland)
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Medtronic Neuromodulation
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
Wright Medical Technology
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Wright Medical Technology
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Wright Medical Technology
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Wright Medical Technology
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Philips Medical Systems
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
CooperSurgical
The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.