FDA Device recall Z-0841-2020
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) by Palodex Group Oy, citing 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 an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0841-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-07 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Palodex Group Oy |
| Distribution | PA, WI |
Product
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
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.
Identifiers
| code_info | Serial Number: TBD (range from KJ1208178 to KJ1314403) PSU's having nine-digit serial numbers beginning with four di…Serial Number: TBD (range from KJ1208178 to KJ1314403) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0841-2020%22
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