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

Recall Z-0904-2021 — Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

U.S. FDA — Device Enforcement · United States · 2020-11-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0904-2021
Date of alert
2020-11-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Respironics California, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
100011125
Reported risk: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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