BEUDAMED
    FDA Recall Terminated

    Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan.

    Recall: Z-0134-2010 · Initiated August 31, 2009

    Recall

    Recall Number
    Z-0134-2010
    Event Number
    53177
    Firm
    Stryker Imaging
    FEI Number
    3002907767
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2009
    Posted
    November 9, 2009
    Terminated
    April 14, 2010
    Address
    1410 Lakeside Pkwy, Ste 600, Flower Mound, TX, 75028-4027

    Description

    Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan.

    Reason

    Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.

    Action

    Stryker Imaging issued an "Urgent: Device Correction" notice dated August 18, 2009. Customers were notified of the defective product and informed that Stryker will be in contact shortly to coordinate the product correction. Actions to be taken during the interim were also detailed. For further information, contact Stryker Imaging at 1-972-410-7100.

    Distribution

    Nationwide Distribution -- AR, TN, IL, GA, TX, WA, MI, PA, and MS.

    Quantity

    12 devices affected