BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-0303-2008 · Initiated October 3, 2007

    Recall

    Recall Number
    Z-0303-2008
    Event Number
    45474
    Firm
    Stryker Communications
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 3, 2007
    Posted
    January 12, 2008
    Terminated
    June 16, 2008
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    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)

    Reason

    Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.

    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.

    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.

    Quantity

    1,653 cables.