Olympus Corporation of the Americas Recall 90218
Description: Colonovideoscope Model CF-H180AL
Olympus Corporation of the Americas Recall 90218 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1274-2022 |
| Event ID | 90218 |
| Event Description | Colonovideoscope Model CF-H180AL |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of KY. |
| Quantity | 1 unit |
| Recall Reason | A (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 Classification | 20220629 |
| Device Code Info | UDI-DI: 04953170339615 Serial number: 2501131 |
| Center Classification Date | 20220621 |
| Recall Initiation Date | 20220422 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | |
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