GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Reported: September 5, 2018 Initiated: July 24, 2018 #Z-2954-2018
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.
Details
- Recalling Firm
- GE Medical Systems China Co., Ltd.
- Units Affected
- 310 units
- Distribution
- Worldwide
- Location
- Wuxi, N/A
Frequently Asked Questions
What product was recalled? ▼
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems. Recalled by GE Medical Systems China Co., Ltd.. Units affected: 310 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2954-2018.
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