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Recall Observatory FDA recall evidence

Device product

Colonoscope, Model Number PCF-H190DL.

Z-1210-2024

January 11, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93832
Status
Ongoing
Classification
Class II
Quantity
47
Official record key
device-enforcement:Z-1210-2024

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-H190DL; UDI DI: 04953170363672; Serial Number: 2046148, 2046377, 2500549, 2501714, 2602501, 2602549, 2602675, 2602884, 2603086, 2605185, 2605189, 2605279, 2605338, 2605343, 2615621, 2716237, 2716306, 2716379, 2727123, 2727529, 2737897, 2738603, 2839269, 2839284, 2839580, 2840038, 2840130, 2840639, 2840669, 2840719, 2840798, 2840928, 2842302, 2942674, 2942814, 2943131, 2943193, 2943240, 2943296, 2943451, 2943708, 2943820, 2944426, 2944690, 2944765, 2944939, 2945260;

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.

Field note

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