Home / Recalls / Olympus Corporation of the Americas / Z-0078-2023

Z-0078-2023 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 19, 2022
Initiation Date
September 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4184 US; 191 OUS

Product Description

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

Reason for Recall

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.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution to Canada and Japan.

Code Information

UDI-DI: 00821925010475 All units are included.

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