BEUDAMED
    FDA Recall Terminated

    Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.

    Recall: Z-0417-05 · Initiated November 30, 2004

    Recall

    Recall Number
    Z-0417-05
    Event Number
    30763
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 30, 2004
    Posted
    January 27, 2005
    Terminated
    May 13, 2005
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.

    Reason

    A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.

    Action

    The firm has initiated consignee notification by sending a notification letter and acknowledgement of receipt cards to its consignees. Service cards will be issued to firm sales representatives.

    Distribution

    The products were distributed to 114 consignees.

    Quantity

    256 carts with transformers, 20 transformers