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U.S. Department of Health and Human Services

Class 3 Device Recall Extron Electronics Digital Video Interface (DVI) Cable

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  Class 3 Device Recall Extron Electronics Digital Video Interface (DVI) Cable see related information
Date Initiated by Firm October 03, 2007
Date Posted January 12, 2008
Recall Status1 Terminated 3 on June 16, 2008
Recall Number Z-0303-2008
Recall Event ID 45474
510(K)Number K033132  
Product Classification Digital Video Interface (DVI) Cable - Product Code GCJ
Product Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)
Code Information All Lots and Serial Numbers shipped between Oct. 2006 and June 2007.
Recalling Firm/
Manufacturer		 Stryker Communications
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
Manufacturer Reason
for Recall		 Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Firm notified consignees of recall via letter (Urgent Device Recall) on 09/21/07. Consignees were notified that a customer service representative would visit each facility to replace out-of-spec cables with properly shielded cables at no charge.
Quantity in Commerce 1,653 cables.
Distribution Worldwide: USA and Australia, Belgium, Canada, France, Germany, Great Britain, Hong Kong, Japan, Korea, Mexico, Netherlands, New Zealand, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, and The U.A.E.
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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