Recall Z-0839-2020 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Palodex Group Oy
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
| Date | Jan 7, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by letter stating: Urgent Medical Device Correction Dear KaVo Kerr Customer, Palodex Group OY has identified an issue with Soredex DIGORA Optime, KaVo Scan eXam, Instrumentarium Express, and Gendex GXPS-500 Imaging Plate Systems (later called IPS). According to our records, we have delivered to you one or more devices belonging to the serial number range defined in the table below. The Power Supply Unit (PSU) delivered with the device may have a fault requiring correction. Product Soredex DIGORA Optime |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041050 | DIGORA OPTIME (OR DIGORA ONTIME) Soredex Palodex Group OY, Jun 15, 2004 |