Flow-c Anesthesia System — Class II medical device recall Z-0422-2023
Ongoing recall by Getinge Usa Sales Inc, reported 2022-12-14, distributed nationwide. The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and the
| Recall number | Z-0422-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-11-07 |
| Classified | 2022-12-07 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 65 us |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07325710009765, 07325710010457 |
| Serial numbers | 4003, 4777, 4783, 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048 and 50 more |
Product
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Reason for recall
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
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-0422-2023. 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.