BEUDAMED
    FDA Enforcement Class II Terminated

    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.

    Recall: Z-0300-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0300-2019
    Event ID
    80960
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    August 6, 2018
    Classification Date
    October 30, 2018
    Termination Date
    April 10, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.

    Reason

    In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

    Code Info

    Serial Numbers 24077 24221 24256 24237 24263 24327 24297 24283 24288 24289 24172 24174 24186 24129 24277 24142 24304 24109 24176 24049 24058 24039 24234 24323 24105 24295 24121 24230 24276 24194 24281

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.

    Quantity

    31