BEUDAMED
    FDA Enforcement Class II Terminated

    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    Recall: Z-0840-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0840-2020
    Event ID
    84544
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Palodex Group Oy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2020
    Initiation Date
    January 7, 2020
    Classification Date
    January 23, 2020
    Termination Date
    April 15, 2024
    Address
    Nahkelantie 160, Tuusula, N/A, Finland

    Description

    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    Reason

    Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

    Code Info

    Serial Number: GJ1209488, GJ1209489, GJ1209491, GJ1209492, GJ1209493, GJ1209494, GJ1209495, GJ1209496, GJ1209498, GJ1209499, GJ1209504, GJ1209505, GJ1209506, GJ1209507, GJ1209509, GJ1209510, GJ1209511, GJ1209513, GJ1209514, GJ1209516, GJ1211287, GJ1211288, GJ1211289, GJ1211290, GJ1211291, GJ1211292, GJ1211293, GJ1211294, GJ1211295, GJ1211296, GJ1211297, GJ1211298, GJ1211299, GJ1211300, GJ1211301, GJ1211302, GJ1211303, GJ1211304, GJ1211305, GJ1211307, GJ1311619, GJ1311621, GJ1311622, GJ1311623, GJ1311624, GJ1311625, GJ1311626, GJ1311627, GJ1311628, GJ1311629, GJ1311630, GJ1311631, GJ1311632, GJ1311633, GJ1311634, GJ1311635, GJ1311636, GJ1311637, GJ1311638, GJ1311639, GJ1311640, GJ1311641, GJ1311642, GJ1311643, GJ1311644, GJ1311645, GJ1311646, GJ1311647, GJ1311648, GJ1311650, GJ1311651, GJ1311653, GJ1311656, GJ1311658, GJ1311659, GJ1311660, GJ1311661, GJ1311662, GJ1311663, GJ1311664, GJ1311665, GJ1311666, GJ1311669, GJ1311670, GJ1311671, GJ1311672, GJ1311673, GJ1311674, GJ1311675, GJ1311676, GJ1311677, GJ1311678, GJ1311679, GJ1311680, GJ1311681, GJ1311682, GJ1311683, GJ1311684, GJ1311685, GJ1311686, GJ1311722 PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

    Distribution

    US: WI and PA OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

    Quantity

    101