Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)
FDA Recall Z-0302-2008 · Posted 2008-01-12
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Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeGCJ
Date Initiated2007-10-03
Date Terminated2008-06-16
Product Quantity2,255 cables.
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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