BEUDAMED
    FDA Recall Terminated

    Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.

    Recall: Z-0168-2010 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-0168-2010
    Event Number
    53133
    Firm
    Stryker Imaging
    FEI Number
    3002907767
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 31, 2009
    Posted
    November 10, 2009
    Terminated
    January 8, 2010
    Address
    1410 Lakeside Pkwy, Ste 600, Flower Mound, TX, 75028-4027

    Description

    Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.

    Reason

    Product serving as data backup protection does not contain 100% data backup for all NetPractice customers on a daily basis.

    Action

    Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.

    Distribution

    Nationwide Distribution

    Quantity

    55 devices affected