BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis Q.zen ceiling, Model Number 10848354

    Recall: Z-0979-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0979-2022
    Event ID
    89860
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    February 23, 2022
    Classification Date
    April 21, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Q.zen ceiling, Model Number 10848354

    Reason

    If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

    Code Info

    UDI: 4056869010021; Serial Numbers: 111160 111162 111163 111137 111502 111139 111174 111185 111503 111005 111002 111145 111176 111510 111155 111179 111140 111507 111122 111168 111170 111173 111512 111141 111508 111521 111133 111003 111111 111103 111101 111011 111182 111184 111143 111150 111164 111183 111504 111149 111109 111151 111129 111121 111130 111517 111513 111017 111010 111115 111116 111117 111119 111104 111148 111127 111175 111506 111112 111131 111132 111134 111158 111167 111157 111161 111142 111156 111500 111501 111169 111505 111166 111107 111514 111000 111106 111123 111128 111135 Additional Serial Numbers as of 10/4/23: 111125

    Distribution

    US Nationwide.

    Quantity

    81 systems