Ventana HE 600 System, automated slide preparer, for use in laboratories.
Check against the official notice below — it lists the full affected range.
Ventana Medical Systems Inc. is recalling 763 Ventana HE 600 Systems, which are automated slide preparers used in laboratories. The recall was issued due to a potential for fluid leaks inside the instrument that could result in electrical shorts and fires. The affected instruments were distributed across multiple U.S. states and territories as well as numerous countries in Europe, the Americas, Asia, and Australia, encompassing all production lots.
The source document does not specify a remedy or recommended course of action for consumers who possess affected instruments.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Reason for recall: There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire Distribution: 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, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, E Quantity: 763 instruments Lot/code info: All Lots; UDI/DI: 04015630976010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.