Recall Z-0841-2020— Palodex Group Oy
Class II · Terminated
Class II FDA medical device recall by Palodex Group Oy, initiated 2020-01-07, terminated 2024-04-15. It names one FDA 510(k) clearance: K041050. 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..
- Recalling firm
- Palodex Group Oy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-07
- Terminated
- 2024-04-15
- Firm location
- Tuusula, Finland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
KaVo Scan eXam 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.