FDA Publishes Philips Respironics FAQ

WASHINGTON, DC – In response to the widely-reported Philips Respironics voluntary recall, the United States Food & Drug Administration (FDA) published a Q&A. On June 30, 2021, the FDA issued a safety communication: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks.

The most recent Q&A sheds light on topics that many providers are curious about. For example, in response to the question; When will the devices start to be repaired or replaced? The FDA responded last month: Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.

A question about the status of Philips Respironics’ plans for repairing or replacing devices yielded the following response: Philips Respironics’ implementation of a plan to fix the problems with the Philips Respironics products is a high priority for the FDA. The FDA reviewed and concurred with Philips’ Respironics plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations) and DreamStation ST, ASV, AVAPS (All Configurations).

The FDA is committed to using every tool at our disposal to increase the availability of these medical products. The FDA is working with Philips Respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. We are collaborating with other manufacturers and government partners to support availability of CPAP and BiPAP machines.

Philips Respironics has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace products across all the Philips Respironics’ recalled devices, including the Trilogy ventilators, A-series BiPAP machines, C-series BiPAP machines, OmniLab Advanced+, Garbin Plus, Aeris, LifeVen, E30 ventilator, REMstar SE Auto, and E30. The FDA has also initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements. 

Click Here to see the full Q&A.  

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