Recall Z-2954-2018 ยท BSZ Gas-Machine, Anesthesia
GE Medical Systems China Co., Ltd.
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
| Date | Jul 24, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative. |
| Quantity | 310 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151570 | Carestation 620/650/650C Datex-Ohmeda, Inc., Jan 21, 2016 |