On June 30, 2021, the U.S. Food and Drug Administration (FDA) published a safety communication to their website. The FDA communication urges patients using the affected devices to talk to their health care providers to determine a suitable treatment for their health condition. The communication also provides recommendations for patients and health care providers and facilities.
The FDA also notes that they “are working with Philips to evaluate the issue, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company.”
The communication also urges patients to register their devices to Philips’ website and also includes a link to the Medwatch Reporting Form where individuals
Suppliers are encouraged to share these links with their patients. By registering their devices with Philips, patients will help provide useful data on the total number of devices affected. To register affected devices, patients can go to the registration link found under the "Patients, Users, and Caregivers" heading on Philips recall website. Patients are also encouraged to report problems with their devices directly to the FDA here: FDA MedWatch Voluntary Reporting Form.