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.
And Philips’ August 20, 2013, response "did not address the above referenced corrections and removals, and did not provide any information to our office regarding the above events," according to the FDA.
Philips has 15 business days from the date it received the letter to let the FDA know the details of the recall and what steps it took to address the problem and what it will do to prevent it from happening again, according to the letter.