Reported Sep 5, 2018 · Terminated
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
GE Medical Systems China Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · National Hi-Tech · Wuxi, N/A · N/A
Is this the product you have?
- GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
- Lot codes and dates
- (a) 620
- A1Serial
- Numbers(b) 620
623 of 623 codes
SM618060027MASM618160055MASM618160049MASM618120029MASM618120027MASM618120026MASM618120028MASM618190086MASM618190098MASM618190095MASM618190094MASM618190093MASM618190096MASM618190097MASM618060028MASM618060025MASM618060024MASM618060023MASM618060019MASM618060015MASM618060016MASM618060017MASM618130008WASM618130010WASM618130009WASM618130007WASM618130011WASM618130012WASM618200003WASM618200002WASM618200004WASM618200005WASM618120030MASM618120031MASM618120036MASM618160011MASM618160010MASM618120032MASM618120034MASM618120033MASM618120035MASM618120037MASM618100002WASM618100003WASM618100004WASM618100001WASM618100005WASM618100006WASM618100007WASM618100008WASM618100009WASM618100010WASM618100011WASM618100012WASM618160071MASM618210084WASM618070008WASM618070009WASM618070010WASM618070007WA
- A2 Serial Numbers(c) 650
SM618110017WASM618110018WASM618110015WASM618110016WASM618110019WASM618160004WASM618160106WASM618160105WASM618160001WASM618160002WASM618160003WASM618160005WASM618160006WASM618160007WASM618160008WASM618160074WASM618160009WASM618160072WASM618160073WASM618160075WASM618160076WASM618160077WASM618160078WASM618160079WASM618160080WASM618160081WASM618160082WASM618160083WASM618160084WASM618160085WASM618160086WASM618160087WASM618160088WASM618160089WASM618250044WASM618250043WA
- A1 Serial Numbers(d) 650
638 of 638 codes
SM718220050MASM718220049MASM718220047MASM718220056MASM718130036MASM718130035MASM718130034MASM718130037MASM718130033MASM718130038MASM718160041MASM718220057MASM718130032MASM718130031MASM718160040MASM718240011MASM718240014MASM718240009MASM718240013MASM718240016MASM718240010MASM718240012MASM718240015MASM718240017MASM718240018MASM718160067MASM718160066MASM718160069MASM718160068MASM718120012MASM718120013MASM718250011MASM718250010MASM718250009MASM718160024MASM718250001MASM718250012MASM718120017MASM718220046MASM718220055MASM718150004WASM718150003WASM718190014WASM718180029WASM718230020WASM718220015WASM718210010WASM718120003WASM718120002WASM718220017WASM718220016WASM718060023WASM718060022WASM718140008WASM718140009WASM718140010WASM718140007WASM718190033WASM718190034WASM718190030WA
- A2 Serial NumbersSM718120005WA SM718120001WA SM718240053WA SM718240052WA (e) 650c
- A1 Serial Numbers
SM818170005MASM818170002MASM818170001MASM818190002WASM818190001WASM818150002WASM818150001WASM818120001WASM818220001WA
- Amount recalled
- 310 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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