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Recall Observatory FDA recall evidence

Device product

Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.

Z-0078-2023

September 16, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 90876
Status
Ongoing
Classification
Class II
Quantity
4184 US; 191 OUS
Official record key
device-enforcement:Z-0078-2023

Official wording

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.

Code information: UDI-DI: 00821925010475 All units are included.

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Canada and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.