BEUDAMED
    FDA Recall Terminated

    Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

    Recall: Z-0160-2010 · Initiated August 3, 2009

    Recall

    Recall Number
    Z-0160-2010
    Event Number
    53134
    Firm
    Stryker Imaging
    FEI Number
    3002907767
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 3, 2009
    Posted
    November 10, 2009
    Terminated
    January 26, 2010
    Address
    1410 Lakeside Pkwy, Ste 600, Flower Mound, TX, 75028-4027

    Description

    Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

    Reason

    Guardian Services data backup does not contain 100% data for all OrthoPad customers on a daily basis.

    Action

    Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.

    Distribution

    Nationwide Distribution

    Quantity

    85