Reported Feb 21, 2018 · Ongoing
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
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 Dev. Zone · Wuxi · N/A
Is this the product you have?
Carestation 620 A2Carestation 650 A2and Carestation 650c A2
- Lot codes and dates
- Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2,SM717330016WA; UDI No.: 010084068210398521SM617250012WA11170624, 010084068210398521SM617250003WA11170619, 010084068210398521SM617250004WA11170619, 010084068210398521SM617250010WA11170621, 010084068210398521SM617250013WA11170624, 010084068210394721SM717260002WA11170627, 010084068210394721SM717260001WA11170627, 010084068210395421SM817210001WA11170522, 010084068210395421SM817210002WA11170522
181 of 181 codes
SM617240022WA-A2SM617250011WA-A2SM617240010WA-A2SM617240011WA-A2SM617240003WA-A2SM617240012WA-A2SM617240004WA-A2SM717180002WA-A2SM717250002WA-A2SM717230002WA-A2SM717250003WA-A2SM717250011WA-A2SM717250010WA-A2SM817240005WASM817240003WASM817240004WASM617230006WASM617230066WASM617230067WASM617230068WASM617230069WASM617230070WASM617230071WASM617230072WASM617230073WASM617230074WASM617230075WASM617230076WASM617230077WASM617230079WASM617230078WASM617250041WASM617250040WASM617230081WASM617230080WASM617240009WASM617240019WASM617240016WASM617240017WASM617240018WASM617240024WASM617250012WASM617250009WASM617250005WASM617250003WASM617250019WASM617250004WASM617250010WASM617250023WASM617250022WASM617250024WASM617250028WASM617250025WASM617250026WASM617250027WASM617250029WASM617250030WASM617250031WASM617250032WASM617250033WA
- Model No. 1012-9620-000, 1012-9650-000, 1012-9655-000, 1012-9650-002, 1012-9620-002, 1012-9655-002; Serial No. SM617240023WA-A2,
- Amount recalled
- 5,148 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
This product could cause temporary or reversible health problems — stop using it.
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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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