Recall update Phillips Macines

FDA Provides Update on Recalled Philips Machines

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Earlier this year, Philips initiated a recall of certain ventilators, CPAP, and BiPAP machines due to potential health risks related to the foam used in the devices. The company states that this particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and require medical intervention to prevent permanent injury to users.

Now months later the FDA flagged another safety issue with the replacement foam. Philips chose to replace the PE-PUR foam with a silicone-based foam, and the FDA originally approved the plan based on testing provided by Philips. But the FDA now says that information discovered during an inspection of Philips’ manufacturing facility revealed that the silicone foam used in a device marketed outside the U.S. failed a safety test for volatile organic compounds.

“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product.” the agency said in its recall update.

The agency recognizes that many patients will have questions about what this information means for the status of their devices and updated its “Frequently Asked Questions” to provide helpful information to the public.

Dr. Fox may be of help with a temporary appliance for treatment, or consideration with your physician if oral appliance therapy could be an option as an alternative treatment for obstructive sleep apnea.

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