Ventana HE 600 System, automated slide preparer, for use in laboratories.
Reported: July 20, 2022 Initiated: June 1, 2022 #Z-1374-2022
Product Description
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Reason for Recall
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Details
- Recalling Firm
- Ventana Medical Systems Inc
- Units Affected
- 763 instruments
- 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, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam
- Location
- Oro Valley, AZ
Frequently Asked Questions
What product was recalled? ▼
Ventana HE 600 System, automated slide preparer, for use in laboratories.. Recalled by Ventana Medical Systems Inc. Units affected: 763 instruments.
Why was this product recalled? ▼
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1374-2022.
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