FDA recall Z-2025-2023

DRE Medical Group Inc · Class II · device

Product

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.

Reason for recall

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.

Distribution

US: CA, FL

Key facts

Status
Ongoing
Initiation date
2023-05-15
Report date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2023