FDA Device recall Z-0080-2025
Avance CS2 and Avance CS2 Pro
- FDA Device
- Class I
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class I recall of Avance CS2 and Avance CS2 Pro by Datex Ohmeda, citing potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-12 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
Product
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Identifiers
| code_info | GTIN: 00840682102322. Model Numbers: 1009-9050-000, 1011-9050-000, 1009-9002-000, 1009-9212-000. All Serial Numbers. N…GTIN: 00840682102322. Model Numbers: 1009-9050-000, 1011-9050-000, 1009-9002-000, 1009-9212-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2025%22
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