FDA recall Z-0841-2020

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

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

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