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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 Recall
Olympus VISERA OTVS7V Camera Head
see related information
Date Posted October 01, 2010
Recall Status1 Terminated on September 27, 2012
Recall Number Z-2642-2010
Recall Event ID 56593
Premarket Notification
510(K) Number
K083155 
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, Pennsylvania 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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