Tag: FDA recall
Medtronic disables internet updates in CareLink CIEDs due to cybersecurity risks
Medtronic has issued a software update "to address a safety risk caused by cybersecurity vulnerabilities" in 34,000 of their cardiac implantable electronic devices (CIEDs),...
Medtronic: class I recall- manufacturing error preventing electrical shock delivery
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a defect in the manufacturing process. This defect...
Class I recall: HeartStart MRx defibrillator by Philips Electronics
Philips is recalling the HeartStart MRx defibrillator due to a defect in the device's gas discharge tube. The gas discharge tube has micro cracks...
FDA updates Class I recall of St. Jude Medical’s ICDs and...
In October 2016, St. Jude Medical recalled a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to reports of...