BEUDAMED
    FDA Recall Terminated

    Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.

    Recall: Z-1316-2008 · Initiated February 15, 2008

    Recall

    Recall Number
    Z-1316-2008
    Event Number
    46907
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 15, 2008
    Posted
    September 11, 2008
    Terminated
    February 15, 2011
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.

    Reason

    Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.

    Action

    Stryker Endoscopy mailed Urgent Device Correction notices, dated February 14, 2008, to all consignees, and sales representatives will be supplied with a fix to distribute to the user base.

    Distribution

    Worldwide distribution: USA, Canada, Greece, and Germany.

    Quantity

    814 units distributed