On Jan 26, the US FDA provided the following update related to the Philips Respironics Trilogy Evo recall:
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.
More information is available on the FDA website.
trilogy evo recall
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Go To Source For Respiratory Therapy Coverage
RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.
