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FDA publishes Safety Communication for Philips recall

FDA publishes Safety Communication for Philips recall

WASHINGTON – The Food and Drug Administration has issued a Safety Communication regarding the Philips recall of certain respiratory devices. 

According to a bulletin from AAHomecare, the communication summarizes major issues and considerations related to the recall, and encourages patients using BiPAP and CPAP machines to discuss treatment options and alternatives with their healthcare providers, including “Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.” 

The FDA notes that it is working with Philips to evaluate the issue, the scope of the recall and appropriate mitigation strategies. The agency is also analyzing medical device reports related to the affected devices over the period of 2009-21 for reports that could be related to this issue. The communication includes a link to the Medwatch Reporting Form where individuals can report problems with their devices directly to the FDA. 

Additionally, the communication urges patients to register their devices with Philips’ website

AAHomecare said it will continue to work with respiratory stakeholders, clinical groups, government entities and their contractors, and major payers to help expedite replacement equipment and continue high-quality care for patients who continue to use their devices in the near term. Earlier this week, the association sent a letter to the DME medical director to outline challenges providers face due to the recall. 


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