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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 Device Recall OPHIT Optical DVI Extension Module see related information
Date Initiated by Firm April 01, 2008
Date Posted September 29, 2008
Recall Status1 Terminated 3 on January 26, 2010
Recall Number Z-2467-2008
Recall Event ID 49368
510(K)Number K033132  
Product Classification Laparoscope - 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 TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer Reason
for Recall		 Product at times experiences intermittent signal loss due to electromagnetic interference.
FDA Determined
Cause 2		 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 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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = STRYKER COMMUNICATIONS CORP.
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