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Recall Observatory FDA recall evidence

Device product

Colonoscope, Model Number PCF-H180AL.

Z-1209-2024

January 11, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
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

    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.