Z-0840-2020 Class II Terminated

Recalled by Palodex Group Oy — Tuusula

Recall Details

Product Type
Devices
Report Date
January 29, 2020
Initiation Date
January 7, 2020
Termination Date
April 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
101

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

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