BEUDAMED
    FDA Recall Terminated

    Siremobil Compact Mobile X-Ray System

    Recall: Z-0120-06 · Initiated August 1, 2005

    Recall

    Recall Number
    Z-0120-06
    Event Number
    33082
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2005
    Posted
    November 2, 2005
    Terminated
    July 19, 2006
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Siremobil Compact Mobile X-Ray System

    Reason

    Screws may become loose and fall into the OR field during surgery.

    Action

    The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.

    Distribution

    The products were shipped nationwide to a distributor, a physician, and medical facilities

    Quantity

    1 unit