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Escalation: FDA Wants Philips To Repair, Replace Or Give Refunds For Recalled Breathing Machines

 
• By Shawn M. Schmitt

The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.

Philips logo.
• Source: Shutterstock

The US Food and Drug Administration is weighing whether to issue an order to force Philips Respironics to draw up a plan to repair, replace or issue refunds to customers who bought one of the company’s recalled breathing machines.

The order would be carried out under Sec. 518(b) of the Food, Drug, and Cosmetic Act, which gives the agency the authority to force “manufacturers, importers or distributors to...

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