Recall of Philips Respironics Trilogy Evo Universal Ventilators
Philips Respironics is recalling 113,717 Trilogy Evo Universal ventilators due to potential discrepancies in tidal volume when using non-pneumatic nebulizers, classified as a Class I recall by the FDA.
Recall of Philips Respironics Trilogy Evo Universal Ventilators
What Happened
Philips Respironics is recalling their Trilogy Evo Universal ventilators because using non-pneumatic nebulizers with these devices may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Which Products Are Affected
The affected products are the Philips Respironics Trilogy Evo Universal with Software Version 1.05.15.00. This recall involves approximately 113,717 units, with all model numbers, UDIs, and serial numbers included. The products were distributed worldwide, including nationwide in the United States and to countries such as Argentina, Australia, and Canada.
What You Should Do
Consumers who have the affected product should follow the instructions in the letter from Philips Respironics, as this is a firm-initiated voluntary recall. For returns, refunds, or further information, contact the recalling firm, Philips Respironics, Inc., at their address: 1001 Murry Ridge Ln, Murrysville, PA 15668-8517.
Why This Matters
This recall affects over 113,000 devices used for continuous home ventilation, and its Class I classification by the FDA indicates a significant potential for serious health risks.
Source
FDA Recall Notice: Z-1617-2026. For more details, refer to the FDA website.
Source: FDA Official Notice