AED recall
This article was originally published in The Gray Sheet
Executive Summary
Medtronic withdraws 1,924 Lifepak 500 monophasic automated external defibrillators manufactured in 1997, because a defect may prevent them from reading heart rhythm. The recall accounts for 1% of the devices in use worldwide, Medtronic says in a Feb. 25 release. Following 54 incident reports, the firm distributed recall notices Feb. 3. Medtronic estimates that the flaw would affect about 8% of patients treated with the models and asks customers to contact it for user recommendations and replacement schedules. Medtronic provide free upgrades to the defective AEDs by March 31...
You may also be interested in...
Medtronic LifePak Warning Letter Prompts Meeting With FDA
Medtronic says it is taking steps to improve quality systems initiatives and to ensure that employees observe company procedures, following receipt of a June warning letter for QS lapses
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.