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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus VISERA OTVS7V Camera Head

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  Class 2 Device Recall Olympus VISERA OTVS7V Camera Head see related information
Date Initiated by Firm August 20, 2010
Date Posted October 01, 2010
Recall Status1 Terminated 3 on September 27, 2012
Recall Number Z-2642-2010
Recall Event ID 56593
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
Code Information Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms-Tyler
484-896-5688
Manufacturer Reason
for Recall		 Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type.
FDA Determined
Cause 2		 Labeling mix-ups
Action Asked consignees to return camera heads to correct the labeling.
Quantity in Commerce 217 camera heads
Distribution nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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