Ventana HE 600 System recalled over fire hazard

Recall date

June 1, 2022

Source

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

Official notice title

Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.

Recall number

Z-1374-2022

FDA classification

Class II

Brand / firm

Ventana Medical Systems Inc

Sold / distributed

US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden,…

Why it was recalled

There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

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

What was recalled

Ventana HE 600 System, automated slide preparer, for use in laboratories.