Device product
Colonoscope, Model Number PCF-Q180AL.
Z-1214-2024
Product summary
- Event
- Event 93832
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-1214-2024
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-Q180AL; UDI DI: 4953170307720; Serial Number: 2200140, 2603268, 2808983, 2909332;
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.