Reported Oct 2, 2024 · Ongoing
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0…
Hologic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic Inc · 600 Technology Dr · Newark, DE · 19702-2463
Is this the product you have?
8 of 8 products
| Model / number | Product as published |
|---|---|
ASY-16824 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. |
ASY-16825 | UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. |
ASY-17219 | UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. |
ASY-17220 | UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. |
ASY-17221 | UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. |
ASY-17222 | UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. |
3DM-LIC-SW-UP-V2.3 | UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. |
SDM-LIC-SW-UP-V1.12 | SOFTWARE 2.3 (3DIMENSIONS) 8. |
- Lot codes and dates
- UDI-DI15420045505636, 15420045511897 Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View¿ software
- Amount recalled
- 425 units
Where it was sold
- Nationwide
Why it was recalled
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
This product could cause temporary or reversible health problems — stop using it.
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