FDAFDA · Food and drugs·Recall number Z-0840-2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Published January 29, 2020 · Recall initiated: January 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Palodex Group Oy
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Finland
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