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U.S. Department of Health and Human Services

Class 2 Device Recall VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYFV)

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  Class 2 Device Recall VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYFV) see related information
Date Initiated by Firm July 20, 2023
Date Posted August 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-2480-2023
Recall Event ID 92783
510(K)Number K022445  K221557  
Product Classification Hysteroscope (and accessories) - Product Code HIH
Product Visera Hysterovideoscope Olympus HYF Type V
Code Information Model HYF-V, all serial numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
FDA Determined
Cause 2		 Reprocessing Controls
Action A customer letter was issued on July 20, 2023. Customers were advised that the Instructions for use were updated. Customers are asked to complete a response form of acknowledgement and submit to Sedgwick at olympus8606@sedgwick.com or Fax 866-557-1242.
Quantity in Commerce 363 units
Distribution US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.
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 = HIH and Original Applicant = Olympus Medical Systems Corporation
510(K)s with Product Code = HIH and Original Applicant = OLYMPUS OPTICAL CO., LTD.
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