FDA Issues 518(a) Order Requiring Philips To Fix ‘Inadequate’ Device Recall Notification Program

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FDA Issues 518(a) Order Requiring Philips To Fix ‘Inadequate’ Device Recall Notification Program

Dennis Tosh

March 17, 2022 at 02:35 PM EST

The FDA March 10 issued a Section 518(a) notification order to Philips Respironics instructing the company to inform device users, durable medical equipment (DME) suppliers, distributors, retailers and health care providers of the firm’s June 2021 recall of some of the company’s ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pres... Read More

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FDA Issues 518(a) Order Requiring Philips To Fix ‘Inadequate’ Device Recall Notification Program

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