Class 3 Device Recall OPHIT Optical DVI Extension Module

• Date Initiated by Firm: April 01, 2008
• Date Posted: September 29, 2008
• Recall Status: Terminated 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.
• FEI Number: 3002975342
• 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: 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