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U.S. Department of Health and Human Services

Class 3 Device Recall OPHIT Optical DVI Extension Module

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 Class 3 Recall
OPHIT Optical DVI Extension Module
see related information
Date Posted September 29, 2008
Recall Status1 Terminated on January 26, 2010
Recall Number Z-2467-2008
Recall Event ID 49368
Premarket Notification
510(K) Number
K033132 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a component of the Switchpoint Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT Optical Digital Visual Interface (DVI) Extender is a converter and transmitter for copper and fiber optic DVI signals.
Code Information All lots produced between 1/5/2006 and 12/15/2007.
Recalling Firm/
Manufacturer
Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound, Texas 75028-4026
Manufacturer Reason
for Recall
Product at times experiences intermittent signal loss due to electromagnetic interference.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Firm sent notification letters to consignees on 4/1/2008. The letter informed the customers. The firm plans to replace the affected product. Contact Stryker at !-972-410-7100 for assistance.
Quantity in Commerce 7,599 units
Distribution Nationwide
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 = STRYKER COMMUNICATIONS CORP.
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