FDA Device recall Z-0960-2023
Getinge Flow-c Anesthesia System, Part No. 6887700
- FDA Device
- Class I
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class I recall of Getinge Flow-c Anesthesia System, Part No. 6887700 by Getinge Usa Sales, citing due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0960-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-22 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Getinge Usa Sales |
| Distribution | US |
Product
Getinge Flow-c Anesthesia System, Part No. 6887700
Reason
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
Identifiers
| code_info | Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0960-2023%22
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