Ventana HE 600 Recalled for Electrical Short Risk
Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electrical short/burned components) where no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Ventana Medical Systems Inc is recalling 461 units of the Ventana HE 600 instrument (Model Number: 06917259001, UDI: 04015630976010). The recall covers all lots and includes units distributed worldwide and nationwide in the United States.
The firm identified a cleaning solution leaking issue from the middle staining module of the instrument. This leak allows fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board, which can cause an electrical short and result in burned components.
The affected instruments are used for histologic section samples in anatomic pathology laboratory settings within hospitals, clinics, reference labs, or private labs. Qualified users in these facilities should contact Ventana Medical Systems for instructions on how to address the issue.
The recalled product
- 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 u
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
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