Philips Respironics Trilogy Evo O2 Ventilator Recall

FDA classified a Class I recall for Philips Respironics Trilogy Evo O2 ventilators (Z-1615-2026) due to the risk that non-pneumatic nebulizers connected to these devices may cause a discrepancy between the physician-prescribed tidal volume and the actual tidal volume delivered to the patient. This malfunction could result in inadequate or excessive ventilation, potentially causing serious injury or death. The affected product is the Trilogy Evo O2 with Software Version 1.05.15.00, distributed worldwide including nationwide in the US.

Healthcare providers who have Trilogy Evo O2 ventilators in their inventory must immediately identify affected devices and cease use with non-pneumatic nebulizers. Providers should notify patients using these devices at home and coordinate with Philips Respironics for repair, replacement, or return of the affected products. Patients should not use non-pneumatic nebulizers with Trilogy Evo O2 ventilators until Philips provides a corrected software version or the device is repaired.