Reported Feb 21, 2018 · Ongoing
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
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 A1Carestation 650 A1and Carestation 650c A1
- Lot codes and dates
Model No. 1012-9620-0001012-9650-0001012-9655-0001012-9650-0021012-9620-0021012-9655-002
- Serial Numbers
2,165 of 2,165 codes
SM617100166MASM617100163MASM617100164MASM617100165MASM617100167MASM617100168MASM616460036MASM616460037MASM717200075MASM717200072MASM717200073MASM717200074MASM617300054MASM716390006MASM716390007MASM716390008MASM717020018MASM717020019MASM717020020MASM717020021MASM717020022MASM717020023MASM717020024MASM717020025MASM717200052MASM716300041MASM716300040MASM716300031MASM716480059MASM716480060MASM716510010MASM716510011MASM716510012MASM716510013MASM716510014MASM616400001MASM716380022MASM716380023MASM716380024MASM616250007MASM616460048MASM616460049MASM617240035MASM617240034MASM617170052MASM716480021MASM716480022MASM716480023MASM716480024MASM716480025MASM716480026MASM716480027MASM716480028MASM616460022MASM717020026MASM717020027MASM717020028MASM717020029MASM717020030MASM616250005MA
- 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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