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Recall Observatory FDA recall evidence

Device product

Colonoscope, Model Number PCF-H190L.

Z-1211-2024

January 11, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
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

    reason.no_named_rule · v1.0.0

    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.