Philips Respironics Recalls Certain V60 Ventilators for Expired Adhesive that May Cause Device to Stop With or Without an Alarm

U.S. Food and Drug Administration sent this bulletin at 03/21/2022 10:09 AM EDT

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CDRH Medical Device Recall

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Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

Philips Respironics is recalling certain V60 and V60 Plus ventilators because a subset of these devices had parts that were assembled using an expired adhesive. If the adhesive fails, it could cause the ventilator to stop providing oxygen to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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Questions?

If you have questions about this recall, contact Philips Respironics 24/7 - Customer Care Solutions Center at 1-800-722-9377.