Recall Z-2262-2020— Ventana Medical Systems Inc
Class II · Completed
Class II FDA medical device recall by Ventana Medical Systems Inc, initiated 2019-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in. Reason: The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components..
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-10-04
- Firm location
- Oro Valley, AZ, United States
Product description
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
Reason for recall
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.
Data sourced from openFDA. This site is unofficial and independent of the FDA.