Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2288-2021 — Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

U.S. FDA — Device Enforcement · United States · 2021-07-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2288-2021
Date of alert
2021-07-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Respironics, Inc.
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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