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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