Device product
Colonoscope, Model Number PCF-H190L.
Z-1211-2024
Product summary
- Event
- Event 93832
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-1211-2024
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-H190L; UDI DI: 04953170305191; Serial Number: 2201678, 2201735, 2301759, 2301775, 2301929, 2301930, 2302159, 2302280, 2302281, 2302380, 2302506, 2303832, 2303927, 2404124, 2404132, 2404806, 2404888, 2404967, 2405012, 2405253, 2405290, 2405353, 2517013, 2517120, 2517422, 2517440, 2517541, 2517616, 2517649, 2517705, 2628544;
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.