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

Recall Z-1956-2021 — Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

U.S. FDA — Device Enforcement · United States · 2021-06-14 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1956-2021
Date of alert
2021-06-14
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Philips Respironics, Inc.
Product category
device
Product type
Devices
Reported risk: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
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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