Class I — Maquet Cardiovascular Us Sales, Llc
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 284 units |
| Distribution | Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United … |
| Initiated | 2012-02-20 |
| Classified | 2012-07-06 |
| Terminated | 2015-09-09 |
| Recall number | Z-1925-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Maquet Cardiovascular Us Sales, Llc (Z-1925-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62118/
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