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Olympus Corporation of the Americas Recall 90218

Description: Colonovideoscope Model CF-H180AL

Olympus Corporation of the Americas Recall 90218 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1274-2022
Event ID90218
Event DescriptionColonovideoscope Model CF-H180AL
Product TypeDevices
DistributionUS Nationwide distribution in the state of KY.
Quantity1 unit
Recall ReasonA (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Device Classification20220629
Device Code InfoUDI-DI: 04953170339615 Serial number: 2501131
Center Classification Date20220621
Recall Initiation Date20220422
Recalling FirmOlympus Corporation of the Americas
Initial Notification E-Mail
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