# FDA recall Z-0841-2020

> **Palodex Group Oy** · Class II · device recall initiated 2020-01-07.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-0841-2020
- **Recalling firm:** Palodex Group Oy
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-07
- **Report date:** 2020-01-29
- **Termination date:** 2024-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tuusula, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0841-2020

## Citation

> AI Analytics. FDA recall Z-0841-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0841-2020. Source: US FDA. Licensed CC0.

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