FDA Warns Philips Over Fatal Defibrillator Defects

Law360, New York (April 13, 2011, 7:50 PM EDT) -- The medical device unit of Royal Philips Electronics NV received a warning letter from the U.S. Food and Drug Administration in late March advising the company that its failure to correct defects in its HeartStart defibrillators led to deaths.

The letter, dated March 28, was sent to Philips Medical Systems Inc., and was posted on the FDA’s website this week. The FDA had issued a previous warning letter to Philips in 2009.

According to the letter, FDA inspectors determined that the HeartStart, FRx, FR2+ and HS1...
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