Recall
Active
FDA
Official source
Hologic, Inc: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor)...
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings....
- Company
- Hologic, Inc
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration