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FUJIFILM
FUJIFILM CORPORATION · Model CT-11G · UDI-DI 04547410331608
FCX
Prescription
2
510(k) clearances
551
Adverse events (6 deaths)
2
Recalls
33
Facilities
Description
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-15 | Northgate Technologies, Inc. | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| 2013-09-16 | Pentax Medical Company | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an end |
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