09/01/2021

Philips Begins Remediation

"HME Newswire" Breaking News

Royal Philips has received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month. 

The company has also started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices, which aren’t affected by the recall. 

“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” said Frans van Houten, CEO of Royal Philips. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”  

Philips says more than 80% of the registered affected devices in the U.S. to date are in the first-generation DreamStation product family.  

The company says it remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the U.S.  

Philips announced the recall of certain CPAP devices and ventilators in June to address potential health risk related to the polyester-based polyurethane sound abatement foam component in these devices.