DRE Medical Group Inc recalls Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predete…

Recall date

May 15, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2025-2023

FDA classification

Class II

Brand / firm

DRE Medical Group Inc

Sold / distributed

US: CA, FL

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.