Device product
Colonoscope, Model Number PCF-H180AL.
Z-1209-2024
Product summary
- Event
- Event 93832
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-1209-2024
Official wording
Reason: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Code information: Model Number: PCF-H180AL; UDI DI: 04953170339899; Serial Number: 2005061, 2007000, 2108388, 2108779, 2109211, 2109849, 2200674, 2201253, 2301680, 2800321, 2801450, 2801763, 2802289, 2903612, 2903746, 2903896, 2904201, 2904811;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.