Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Reported: October 19, 2022 Initiated: September 16, 2022 #Z-0078-2023
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 4184 US; 191 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Japan.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.. Recalled by Olympus Corporation of the Americas. Units affected: 4184 US; 191 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2022. Severity: Moderate. Recall number: Z-0078-2023.
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