BEUDAMED
    FDA Recall Terminated

    AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.

    Recall: Z-1254-2009 · Initiated January 8, 2009

    Recall

    Recall Number
    Z-1254-2009
    Event Number
    51560
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    January 8, 2009
    Posted
    May 6, 2009
    Terminated
    September 1, 2009
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.

    Reason

    During interventional use and applications, the possibility exists for liquids to enter the systems.

    Action

    A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.

    Distribution

    Nationwide Distribution.

    Quantity

    240 units