Philips' healthcare arm ($PHG) is facing some flak from the FDA over the 2012 recall of a component for a surgical heating/cooling device that regulators say they were never notified about.
The FDA's Dec. 20 warning letter revolves around Philips' InnerCool RTx device, which is designed to help cool patients dealing with strokes or other ischemic-related health crises.
Regulators note in the letter that Philips pursued a recall in January 2012 so it could replace the InnerCool main control board after reports that it had generated low patient temperature readings, which would make the device deliver more heat to a patient when it wasn't needed. The FDA knocked Philips for not providing any information about the action, something that's required within 10 days of initiating what regulators formally term "a correction and removal" action.
The FDA noted that Philips issued an initial response to regulators on Aug. 20, but said it didn't pass muster. Philips is now required to demonstrate detailed steps it has taken to correct the violation and also show how it will prevent similar actions from happening in the future.
Philips could not be reached for comment at deadline. But the Dutch consumer and healthcare electronics giant has had at least one other dustup with the FDA in recent months. In December, the FDA issued a safety alert to warn consumers that a number of Philips automated external defibrillators may still fail to deliver the shock needed in an emergency, despite a recall initiated more than a year ago to address the issue.
- here's the full FDA warning letter