Recall archive / FDA device enforcement
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a prede... — FDA record Z-2025-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- DRE Medical Group Inc
- Quantity
- 22 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2025-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | USI-DI: 00884838009868 Serial Numbers: Serial Number 100043954 100050078 100052760 100052848 100054619 100054626 100055277 100055557 100058549 100058566 100058837 100058995 100060228 100065373 100069520 100070487 100071122 100072691 100078379 100080232 100080844 201003462 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA, FL
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- May 15, 2023
- Center classification date
- Jun 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.