BEUDAMED
    FDA Recall Terminated

    Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)

    Recall: Z-1383-2012 · Initiated February 16, 2012

    Recall

    Recall Number
    Z-1383-2012
    Event Number
    61483
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 16, 2012
    Posted
    April 9, 2012
    Terminated
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)

    Reason

    During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250

    Action

    Siemens initiated a recall/correction on February 16, 2012 by issuing Update Instruction XP056/11/S to the affected customers. All screws on the unit support on AXIOM Luminos dRF units will be replaced by a Siemens service engineer. For information regarding this recall call 610-219-4834.

    Distribution

    Nationwide Distribution including California

    Quantity

    2