Ventana HE 600 System, automated slide preparer, for use in laboratories.
Summary
The FDA issued a Class II for Ventana HE 600 System, automated slide preparer, for use in laboratories. by Ventana Medical Systems Inc. Reason: There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire.
Details
Source
Device Recall
External ID
Z-1374-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Lot/Code Info: All Lots; UDI/DI: 04015630976010
Quantity Affected: 763 instruments
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, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-01
Company
Oro Valley, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ventana Medical Systems Inc has 8 FDA actions in our database, including 4 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ventana Medical Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ventana Medical Systems Inc have FDA actions?
Ventana Medical Systems Inc has 8 FDA actions in our database, including 4 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1374-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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