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DIGITAL DIAGNOSTICS SYSTEM
Hologic, Inc. · Model DIGITAL CYTOLOGY IMAGER · UDI-DI 15420045513877
QYV
Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
1
Facilities
Description
The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-23 | Hologic, Inc | 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 settin |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.