FDAOctober 4, 2019device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Completed
Brands named
ventana medical systemsventanaventana medical
UPCs
0691725900104015630976010
Recall history
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