 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Today, the U.S. Food and Drug Administration (FDA) is providing an update related to the recall of certain Philips Respironics ventilators. In December 2021, Philips Respironics initiated a recall of certain Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021 with specific serial numbers. The FDA classified this recall as a Class I recall in January 2022. These devices were not included in the June 2021 recall of Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. Questions? The FDA.gov website includes Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions to address questions about the recalls and provide additional resources with more information. Customers in the U.S. with questions about the Trilogy Evo recall should contact Philips Respironics at 1-800-722-9377 or email Respironics.repair@philips.com. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. | 
No comments:
Post a Comment