Philips Given Warning by FDA
Philips NV confirms that it was issued a warning by the Food and Drug Administration because of problems with its external defibrillators. Jayson Otke, a company spokesman, said that the FDA sent Philips a warning letter on January 29, but that the company quickly responded to the FDA's concerns with measures that Philips is taking to address the concerns. Otke said that more training will be provided for employees who inspect the component parts and that the specifications for parts will be reviewed with suppliers.
Philips issued warning by FDA over problems with defibrillators
Philips voluntarily recalled 2,000 defibrillators after the FDA conducted a routine inspection of a U.S. facility. The external defibrillator market makes up less than 1 percent of Philips' global sales.
Related Links:
Legal View: Unsafe Drugs
Philips recalled 2,000 defibrillators in 2006; no financial impact
U.S. FDA Says More Action Needed on Philips AEDs
Philips Issued Warning by FDA over Problems with Defibrillators
So Can You Trust Your Pacemaker?