BEUDAMED
    FDA Recall Terminated

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    Recall: Z-1445-2015 · Initiated March 19, 2015

    Recall

    Recall Number
    Z-1445-2015
    Event Number
    70830
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 19, 2015
    Posted
    April 14, 2015
    Terminated
    August 6, 2015
    Address
    40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, 19355-1418

    Description

    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    Reason

    potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

    Action

    A customer notification, dated March 19, 2015, was distributed to all affected customer via AX018/15/S. Additionally, Siemens has initiated an inspection of Artis Q/ Q zen systems via Update Instruction AX017/15/S.

    Distribution

    Nationwide

    Quantity

    139