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Recall Observatory FDA recall evidence

Device product

Colonoscope, Model Number CF-HQ190L.

Z-1207-2024

January 11, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 93832
Status
Ongoing
Classification
Class II
Quantity
97
Official record key
device-enforcement:Z-1207-2024

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-HQ190L; UDI DI: 04953170305115; Serial Number: 2082724, 2082896, 2082936, 2083461, 2083765, 2084560, 2085050, 2186261, 2187110, 2187274, 2187811, 2188037, 2188206, 2200530, 2201625, 2201677, 2201844, 2202345, 2288483, 2288940, 2289129, 2289391, 2289421, 2289572, 2290978, 2291472, 2303312, 2304024, 2304070, 2314598, 2315390, 2391750, 2391772, 2391857, 2392281, 2417328, 2417450, 2417702, 2417736, 2417755, 2418202, 2418754, 2418843, 2419006, 2419007, 2419105, 2510489, 2510795, 2510801, 2511164, 2512292, 2512458, 2512470, 2512569, 2512817, 2513285, 2524619, 2524916, 2625144, 2635605, 2635832, 2636020, 2636500, 2636782, 2637892, 2659060, 2659357, 2759754, 2761671, 2762243, 2772492, 2773247, 2773259, 2773324, 2773552, 2874236, 2875490, 2875615, 2875616, 2875656, 2876636, 2876811, 2876877, 2877237, 2877319, 2877901, 2978291, 2978331, 2978640, 2979287, 2979510, 2980281, 2980304, 2980541, 2981322, 2982038, 2982143;

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.