FLOW-I Anesthesia System The system is intended for use in… — Class I medical device recall Z-1925-2012
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2012-07-18, distributed nationwide. A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation m
| Recall number | Z-1925-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2012-02-20 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CH, CN, CZ, DE, EC, ES, FI, FR, GB, IE, IL, IN, IT, LV, NL, NO, PL, PT, RO, RS, RU, SE, SG, TH, ZA |
| Quantity | 284 units |
| Serial numbers | 1170 |
| Model numbers | 6677300 |
Product
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
Reason for recall
A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.
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-1925-2012. 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.