Palodex Group Oy recalls KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Recall date

January 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0841-2020

FDA classification

Class II

Brand / firm

Palodex Group Oy

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)