Recall Z-2025-2023— DRE Medical Group Inc
Class II · Ongoing
Class II FDA medical device recall by DRE Medical Group Inc, initiated 2023-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- DRE Medical Group Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-15
- Firm location
- Louisville, KY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.