FDA Device recall Z-1925-2012
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients…
- FDA Device
- Class I
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class I recall of FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients… by Maquet Cardiovascular Us Sales, citing 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 swit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1925-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-02-20 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number :6677300 Serial Number : 1170 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1925-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.