Device product
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Z-0840-2020
Product summary
- Firm
- Palodex Group Oy
- Event
- Event 84544
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101
- Official record key
device-enforcement:Z-0840-2020
Official wording
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 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
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
Derived failure modes
-
Unknown
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.