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Recall Observatory FDA recall evidence

Device product

Colonoscope, Model Number CF-H180AL.

Z-1205-2024

January 11, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93832
Status
Ongoing
Classification
Class II
Quantity
36
Official record key
device-enforcement:Z-1205-2024

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: CF-H180AL; UDI DI: 4953170339608; Serial Number: 2001426, 2001524, 2001614, 2002139, 2002212, 2002285, 2103817, 2104137, 2104581, 2105255, 2105976, 2107112, 2207880, 2207929, 2207940, 2309317, 2601078, 2601096, 2601255, 2601368, 2601700, 2702380, 2702460, 2702478, 2702805, 2703697, 2704366, 2704490, 2806996, 2807975, 2900004, 2900185, 2900249, 2908770, 2909110, 2909884;

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.