BEUDAMED
    FDA Enforcement Class II Terminated

    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

    Recall: Z-1501-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1501-2020
    Event ID
    85029
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 10, 2020
    Classification Date
    March 16, 2020
    Termination Date
    August 31, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

    Reason

    The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

    Code Info

    Serial Nos. 20113 20034 21100 21086 21113 21088 21103 21221 21223 21224 21085 20045 20093 20110 21066 21031 21139 21006 20155 21112 21122 21185 20088 20089 20106 20107 21052 21089 21213 20167 21098 21174 21057 21101 21116 21117 21118 21120 21091 21092 21037 21076 21077 21200 21203 21209 20149 21163 21172 21171 21173 20094 21115 20047 21194 20193 21211 21212 21186 21188 21094 21039 21040 21108 20035 20185 21061 21065 21205 21095 21148 21189 21140 21175 21023 21001 21127 21123 21013 20159 21160

    Distribution

    US Nationwide distribution in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA and WI.

    Quantity

    81 US/ 308 worldwide