Z-0842-2020 Class II Terminated
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
- 4,563 Total Globally (all products)
Product Description
Instrumentarium Dental Express 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: TBD (range from IJ1208217 to IJ1313309) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX