FDA Device recall Z-1278-2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/RE…
- FDA Device
- Class I
- terminated
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class I recall of Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/RE… by Getinge Usa Sales, citing potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, pre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1278-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-05-02 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Getinge Usa Sales |
| Distribution | CO, FL, IN, MO, NJ, VA |
Product
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Reason
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Identifiers
| code_info | UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047,…UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1278-2022%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.