BEUDAMED
    FDA Recall Terminated

    Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.

    Recall: Z-1198-2010 · Initiated December 29, 2008

    Recall

    Recall Number
    Z-1198-2010
    Event Number
    50777
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 29, 2008
    Posted
    March 23, 2010
    Terminated
    March 24, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.

    Reason

    Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor component in the device may cause the device to power off during surgery or to fail to boot up at all. The risk includes delay and interruption of ongoing surgical procedures.

    Action

    Recall initiated 12/29/2009. Sales representatives were notified via phone and e-mail, while product advisory notices were sent to consignees via FedEx. Consignees are provided with a response form, and are instructed to run a software correction.

    Distribution

    Product was distributed throughout the US and to Argentina, Brazil, Canada, Chile and Latin America, as well as to 16 government facilities.

    Quantity

    884 devices