Device product
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Z-2290-2014
Product summary
- Event
- Event 68753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98 units US; 1108 units OUS
- Official record key
device-enforcement:Z-2290-2014
Official wording
Reason: The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Code information: Model No. OF-B130 OF-B194, all units.
Distribution pattern: Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
Derived failure modes
-
Unknown
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.