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

Recall Z-0882-2023 — Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R10546

U.S. FDA — Device Enforcement · United States · 2022-12-07 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0882-2023
Date of alert: 2022-12-07
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Philips Respironics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00606959429055

Reported risk: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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