Philips Respironics V60 Ventilator-Intended to mechanically control… — Class II medical device recall Z-2025-2023
Ongoing recall by DRE Medical Group Inc, reported 2023-07-05, distributed in CA, FL. Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious
| Recall number | Z-2025-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRE Medical Group Inc, Louisville, KY, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-06-28 |
| Reported by FDA | 2023-07-05 |
| Distributed | CA, FL |
| Quantity | 22 units |
| UPC / GTIN / UDI-DI | 00884838009868 |
| Serial numbers | 100043954, 100050078, 100052760, 100052848, 100054619, 100054626, 100055277, 100055557, 100058549, 100058566, 100058837, 100058995, 100060228, 100065373, 100069520, 100070487, 100071122, 100072691, 100078379, 100080232, 100080844, 201003462 |
| Model numbers | R1053618, R1076709 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2025-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.