Recall Z-2954-2018— GE Medical Systems China Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2018-07-24, terminated 2020-12-16. It names one FDA 510(k) clearance: K151570. 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..
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-24
- Terminated
- 2020-12-16
- Firm location
- Wuxi, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.