On March 8, 2022, FDA held a teleconference and informed Philips that, due to the serious risk posed by the Recalled Products, and lack of effectiveness of Philips’ communications with the public regarding the risks presented by the Recalled Products, the Agency was considering issuing a notification order to Philips under section 518(a). On March 9, 2022, FDA held another teleconference at Philips’ request to discuss whether an order under section 518(a) is necessary.
FDA acknowledges that Philips expressed its willingness to work cooperatively with FDA and to take the actions FDA discussed during the March 8, 2022
Accordingly, pursuant to section 518(a) of the Act, Philips is ordered to notify all health professionals who prescribe or use the Recalled Products, and other persons (including consignees, distributors, retailers, and device users) who should be notified, of the recall and the health risks presented by the Recalled Products within the next 45 days as follows:
- Notify consignees and users of the Recalled Products, including patients, consumers and healthcare providers, regarding the recall and the health risks presented by the Recalled Products. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Philips may implement the mandated notification to patients, healthcare providers and consumers in the following ways:
- Request each consignee to provide you with contact information for each patient, consumer or healthcare provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device.
- In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips’ notification, each patient, consumer or healthcare provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips’ website, and provides instruction on how they can register their device.
- Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page.
- Provide a link for healthcare providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PURPE foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. The information currently available on Philips’ website is vague, and does not provide healthcare providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients.
- Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device.
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