Recall Z-1274-2022 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Colonovideoscope Model CF-H180AL
| Date | Apr 22, 2022 |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide a service loaner device in an effort to not disrupt patient care. Contact: 647-999-3203 or at Cynthia.Ow@Olympus.com |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100584 | EVIS EXERAII 180 SYSTEM Olympus Medical Systems Corporation, Jul 2, 2010 |