FDA Device recall Z-2954-2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems by Ge Medical Systems China, citing on systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2954-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-24 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems China |
| Distribution | n/a |
Product
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Reason
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.
Identifiers
| code_info | (a) 620, A1: Serial Numbers: SM618060027MA SM618160055MA SM618160049MA SM618120029MA SM618120027MA SM618120026M…(a) 620, A1: Serial Numbers: SM618060027MA SM618160055MA SM618160049MA SM618120029MA SM618120027MA SM618120026MA SM618120028MA SM618190086MA SM618190098MA SM618190095MA SM618190094MA SM618190093MA SM618190096MA SM618190097MA SM618060028MA SM618060025MA SM618060024MA SM618060023MA SM618060019MA SM618060015MA SM618060016MA SM618060017MA SM618130008WA SM618130010WA SM618130009WA SM618130007WA SM618130011WA SM618130012WA SM618200003WA SM618200002WA SM618200004WA SM618200005WA SM618120030MA SM618120031MA SM618120036MA SM618160011MA SM618160010MA SM618120032MA SM618120034MA SM618120033MA SM618120035MA SM618120037MA SM618100002WA SM618100003WA SM618100004WA SM618100001WA SM618100005WA SM618100006WA SM618100007WA SM618100008WA SM618100009WA SM618100010WA SM618100011WA SM618100012WA SM618160071MA SM618210084WA SM618070008WA SM618070009WA SM618070010WA SM618070007WA SM618070011WA SM618070006WA SM618200028WA SM618200027WA SM618150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2954-2018%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.