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

Recall Z-2025-2023 — Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

U.S. FDA — Device Enforcement · United States · 2023-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2025-2023
Date of alert
2023-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DRE Medical Group Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838009868
Reported risk: Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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