Philips healthcare criticized by FDA for not reporting device recall

The USFDA has sent a warning letter to Philips Healthcare, which is a device manufacturing company for failing to inform FDA about the recall of one of its product, the InnerCool RTx device and to replace it main control board. As stated by the FDA, the recall was initiated because of the reports of low patient temperature readings. This could lead to delivering extra heat energy to the patient.

For a device manufacturing company, the recall of a medical device is one of most grave actions that may be required in order to promote patient safety or due to a manufacturing defect in the said device. Most of these recalls are initiated by the manufacturing companies in the US, but are coordinated by the US health regulator, USFDA. As given under 21 CFR 806, device manufacturers need to submit information regarding the product name, model, details of approval, lot or unit number and other details along with the reason for the recall to USFDA.

In this case, as stated by FDA, Philips Healthcare failed or refused to provide information regarding the device, subject to the recall within the 10-day reporting period as required. In following correspondence with FDA, the company also has failed to provide a reason for its inability to meet reporting requirements.