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U.S. Department of Health and Human Services

Class 2 Device Recall Berkeley VC10 Vacuum Curettage System

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  Class 2 Device Recall Berkeley VC10 Vacuum Curettage System see related information
Date Initiated by Firm September 16, 2022
Date Posted October 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0078-2023
Recall Event ID 90876
510(K)Number K171440  
Product Classification Curette, suction, endometrial (and accessories) - Product Code HHK
Product Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Code Information UDI-DI: 00821925010475 All units are included.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
484-896-5000
Manufacturer 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.
FDA Determined
Cause 2		 Labeling design
Action On September 16, 2022, the recalling firm notified affected customers through "URGENT Medical Device Field Corrective Action" letters. Customers were informed that the following new warning will be added to the IFU: Do not use replacement parts or accessories that are not compatible with the VC-10 system. Use of noncompatible accessories could lead to reduced system functionality and/or patient injury such as perforation, bleeding, and may require additional intervention. Refer to Section 11 for all accessories compatible with the VC-10 system. Customers should notify their users about risks associated with using non-compatible collection canisters and/or accessories and remind them to follow the list of compatible accessories outlined in Section 11 of the IFU. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. " Go to https://olympusamerica.com/recall. Enter the recall number 0414 " Enter your name and mailing address. Olympus will supply a copy of the revised IFU at a later date If you have distributed these devices outside your facility, please notify your customers of this matter immediately. If you have any questions, call (647) 999-3203 or email: Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
Quantity in Commerce 4184 US; 191 OUS
Distribution Domestic distribution nationwide. Foreign distribution to Canada and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HHK and Original Applicant = Gyrus ACMI
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