Olympus Corporation of the Americas Recall 90876
Description: Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Olympus Corporation of the Americas Recall 90876 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0078-2023 |
| Event ID | 90876 |
| Event Description | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity. |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada and Japan. |
| Quantity | 4184 US; 191 OUS |
| Recall Reason | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10. |
| Device Classification | 20221019 |
| Device Code Info | UDI-DI: 00821925010475 All units are included. |
| Center Classification Date | 20221011 |
| Recall Initiation Date | 20220916 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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