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FDA to Philips: Improve communication on recall 

FDA to Philips: Improve communication on recall 

WASHINGTON – The U.S. Food and Drug Administration says efforts by Philips Respironics to notify patients and others of its recall of certain ventilators and CPAP and BiPAP devices and the risk of harm from the polyester-based polyurethan (PU-PUR) sound abatement foam used in those products have been “inadequate.” 

The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all device users, DME suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the products. 

“The FDA has heard the frustration expressed by patients and DME suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Taking this action enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.” 

The order also directs Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall, and to provide instructions for device users to register their devices on the Philips website.  

Additionally, the FDA recommends that Philips provide monthly updates to device users who register their devices on the Philips website that include information on expected time for replacement and current rate of replacement of recalled devices, and provide detailed information to device users, DME suppliers, distributors, retailers, and health care providers on the replacement process.  

The same day the FDA issued the notification order, Philips provided an update on the recall, saying it has reached the vast majority of the installed base in the U.S. through two rounds of customer and patient outreach. It says about 2.6 million devices have been registered. 

“Based on feedback from the FDA, Philips Respironics will be working with its DME customers to allow the company to directly contact those patients and other end-users that may not yet have received notice of the recall,” the company stated. 

Philips also says it continues to use its mobile application DreamMapper to send notifications to patients and consumers about the recall. The notifications direct them to the recall website for information on the process of registering and maintaining such registration for a replacement device. 

To date, Philips says it has shipped more than 650,000 replacement devices to customers in the U.S. and in the fourth quarter of this year it plans to complete the repair and replacement program. 


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