Recall Z-1374-2022— Ventana Medical Systems Inc
Class II · Ongoing
Class II FDA medical device recall by Ventana Medical Systems Inc, initiated 2022-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Ventana HE 600 System, automated slide preparer, for use in laboratories.. Reason: There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire.
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-01
- Firm location
- Oro Valley, AZ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.