The recall of a medical device is among the most serious actions a company can take in response to a safety issue or defect being associated with a device. In the US, the Food and Drug Administration (FDA) coordinates much of those recalls, which are most often voluntarily initiated by companies.

But coordinating those recalls requires knowing about them, and device manufacturers are required to notify the agency of any recall under 21 CFR 806.

And when companies don't meet that requirement, regulators express their anger in the most constructive way they know how: With a sternly written Warning Letter.

Warning Letter

In a Warning Letter sent in late December 2013 and made public this week, FDA chastised Philips Healthcare for allegedly failing to inform FDA of a recall the firm initiated in January 2012 to replace the main control board of its InnerCool RTx device.

"This correction was initiated due to reports of low patient temperature readings which could cause the console to deliver additional heat energy to the patient," FDA recounted in the letter.

But despite the risks to patients, FDA said Philips, "failed or refused to furnish material or information respecting the device" subject to the recall within the required 10-day reporting period. In subsequent correspondence with FDA, the company failed to provide a reason for the alleged failure to meet reporting requirements, the agency wrote in the letter.

Recall Reporting: The Regulatory Basics

So what should the company have done under normal circumstances? In February 2013, FDA issued a new guidance document explaining the nuances of its recall procedures, including the differences between a recall and a stock recall/recovery.

Under 21 CFR 806, manufacturers are required to submit to FDA various information, including the product name, model, approval or clearance number, lot/unit number, and a reason for the recall.

The latter should, according to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect and any information on how users should protect themselves in the meantime.

Recalls are further defined in a newer guidance, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements, in which FDA explains that "Only changes to devices to remedy a violation of the laws administered by FDA and against which the agency would initiate legal action fall within the definition of a medical device recall."

"For example, if a device is being corrected to address a Quality System violation (see 21 CFR part 820), the correction would generally be considered a recall," FDA wrote in the guidance. Meanwhile, if the device has no violations, it would be considered a product enhancement or stock recall.

Any device that fails to meet specifications, fails to perform as intended, is below the quality the device represents itself as having, or is adulterated or misbranded would constitute a violation, and would thus constitute a recall if removed from the market.

FDA's Warning Letter doesn't explain how Philips failed (allegedly) to comply with 21 CFR 806, but explains that failure to comply in the future could result in the agency taking enforcement action against Philips.

FDA Warning Letter to Philips