Recall of Philips Respironics Trilogy Evo O2 Ventilator for Safety Issue
Philips Respironics is recalling 113,717 units of its Trilogy Evo O2 ventilator due to potential discrepancies in tidal volume when using non-pneumatic nebulizers.
Recall Article: Philips Respironics Trilogy Evo O2
What Happened
Philips Respironics, Inc. is initiating a voluntary recall of its Trilogy Evo O2 ventilator devices because using non-pneumatic nebulizers 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 O2 with Software Version 1.05.15.00. This includes all model numbers, all UDIs, and all serial numbers. A total of 113,717 units are affected, with distribution nationwide in the United States and to various international countries.
What You Should Do
Consumers who have received a letter from the firm should follow the instructions provided as part of this voluntary recall.
Why This Matters
This recall is significant because the discrepancy could impact patient safety for those using the ventilator for breathing support, potentially leading to health risks.
Source
This information is from the FDA, recall number Z-1615-2026.
Source: FDA Official Notice