BEUDAMED
    FDA Recall Terminated

    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

    Recall: Z-0297-2019 · Initiated August 3, 2018

    Recall

    Recall Number
    Z-0297-2019
    Event Number
    81007
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 3, 2018
    Terminated
    November 26, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

    Reason

    Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning

    Action

    Siemens Healthineers issued Urgent Medical Device Correction notice dated August 3, 2018, informing potentially affected users via Safety Advisory Notice XP029/18/S to advise of the problem, risk to health, action to be taken (it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient). The service organization will contact to arrange a date to perform this corrective action with Update Instruction XP031/18/S. Contact service organization for an earlier appointment at 1-800-888-7436. Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP031/18/S.

    Distribution

    US nationwide distribution

    Quantity

    35 units