Device product
Colonoscope, Model Number PCF-H190TL.
Z-1212-2024
Product summary
- Event
- Event 93832
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1212-2024
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-H190TL; UDI DI: 04953170420702; Serial Number: 2110150;
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.