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Olympus Corporation of the Americas Recall 93832

Description: Colonoscope, Model Number CF-H180AL.

Olympus Corporation of the Americas Recall 93832 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1205-2024
Event ID93832
Event DescriptionColonoscope, Model Number CF-H180AL.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity36
Recall ReasonSpecific 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.
Device Classification20240306
Device Code InfoModel 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;
Center Classification Date20240229
Recall Initiation Date20240111
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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