Trilogy EV300 — Class II medical device recall Z-2289-2021
Ongoing recall by Philips Respironics, Inc., reported 2021-08-25, distributed nationwide. Two software issues have been identified related to pressure increase in the device: The first issue is descri
| Recall number | Z-2289-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2021-07-26 |
| Classified | 2021-08-13 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Reason classes | software |
Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Reason for recall
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2289-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.