FDA WARNING_LETTER - Philips Healthcare - July 31, 2013

During an FDA inspection from July 29-31, 2013, Philips Healthcare, Inc., located in San Diego, California, was found to be manufacturing the InnerCool RTx Endovascular System, classified as a device. The inspection revealed that these devices are misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, due to the firm's failure to furnish required material or information under section 519 of the Act and 21 CFR Part 806, specifically regarding Reports of Corrections and Removals.

The firm failed to submit required information to the FDA within 10 days of initiating a correction or removal, as mandated by 21 CFR 806.10(b). Specifically, in January 2012, the firm initiated a recall to replace the Main Control Board (MCB) on InnerCool RTx devices from specific lots due to reports of low patient temperature readings, which could cause the console to deliver additional heat energy.

The firm's response dated August 20, 2013, was deemed inadequate as it did not address the referenced corrections and removals or provide information about these events. Philips Healthcare is required to contact FDA Recall Coordinators to provide the appropriate information as per 21 CFR 806.10(c)(1).

The FDA requires prompt action to correct these violations.