FDA dings Philips on InnerCool RTx component recall

Wed, 01/15/2014 - 5:09pm
Mass Device

The FDA issues a warning letter to Philips over its late notification for the recall of a component of its InnerCool RTx temperature control device.

The FDA dinged Philips for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month.

Philips issued a recall in January 2012 of the main control board for the InnerCool device, which is used to raise or lower the body's core temperature, according to the warning letter.

But Philips "failed or refused to furnish material or information respecting the device" within the 10-day window mandated by the federal watchdog agency, according to the letter. The recall was prompted by the potential for the control board to generate low patient temperature readings, according to the agency.


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