Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Reported: January 29, 2020 Initiated: January 7, 2020 #Z-0839-2020
Product Description
Soredex DIGORA Optime 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.
Details
- Recalling Firm
- Palodex Group Oy
- Units Affected
- 297
- 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
- Location
- Tuusula
Frequently Asked Questions
What product was recalled? ▼
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER). Recalled by Palodex Group Oy. Units affected: 297.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0839-2020.
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