Tag Archives: St. Jude

FDA Classifies St. Jude Defibrillators as Class 2 Recalls for Cybersecurity Updates

We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware updates to St. Jude defibrillators as Class 2 recalls, which is the medium-severity category of classifications that is applicable to issues … Continue Reading

Abbott Laboratories Releases Patches for Cardiac Devices

Abbott Laboratories has issued software patches to some of its implantable cardiac devices (manufactured by St. Jude) for cybersecurity flaws and battery issues that have plagued the devices, necessitating the U.S. Food and Drug Administration (FDA) to previously issue warnings to patients about the devices [view related posts here and here]. There are more than … Continue Reading

St. Jude Medical on Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the cybersecurity of its in-home monitoring system, known as Merlin@home. The monitoring system is wireless and is connected to St. … Continue Reading
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