Trilogy Evo
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Trilogy EVO. [Device]. Model: Trilogy Evo, Trilogy Evo O2; Trilogy EV300. Affected: Update to latest software version 1.06.15.00.; Update to latest software version 1.06.15.00.. Also covers: Trilogy EV300
- Reason
- The manufacturer has become aware that Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices do not comply with the Obstruction Alarm requirements specified within ISO 80601-2-12 Clause 201.12.4.108 and ISO 80601-2-72 Clause 201.12.4.107., Philips Respironics has assessed this problem and determined that there is a potential for patients that are using a Trilogy Evo device to experience harm as a result of a delay in the obstruction alarm. The delay in an obstruction alarm could result in a delay of a patient or caregiver addressing the problem causing: Respiratory Discomfort,...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-23
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/19135140-3382-440c-975e-4fd24154b83a