FDA recall, , Moderate risk
Hologic Selenia Dimensions and 3Dimensions Mammography Systems
Selenia Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.
Summary by Recall Canary from the FDA notice
What happened
Hologic, Inc. of Marlborough, Massachusetts is recalling Selenia Dimensions Mammography Systems and 3DIMENSIONS Mammography Systems because complaints have been received of systems developing loose, missing, or broken internal bolts over time. The recall began April 8, 2026, and was added to the FDA's Enforcement Report on May 12, 2026. Distribution is US Nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI and model code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Selenia Dimensions Mammography Systems.
- UDI-DI
- 15420045510616
- 15420045517783
- 15420045510753
- 15420045510760
- 15420045510623
- 15420045510630
- 15420045510647
- 15420045510654
- 15420045510661
- 15420045510678
- 15420045510685
- 15420045510692
- 15420045510708
- 15420045510715
- 15420045510722
- 15420045510739
- 15420045510746
- 15420045510777
- 15420045510784
- Model code
- SDA-SYS-3000-2D-HTC
- SDA-SYS-3000-3D
- SDM-SYS-6000-2D
- SDM-SYS-6000-3D
- SDM-00001-2D
- SDM-00001-3D
- SDM-00001-M2D
- SDM-00001-M3D
- SDM-05000-2A2
- SDM-05000-2A3
- SDM-05000-2AC
- SDM-05000-2D2
- SDM-05000-2D3
- SDM-05000-2DC
- SDM-05000-3D2
- SDM-05000-3D3
- SDM-05000-3DC
- SDM-SYS-9000-2D
- SDM-SYS-9000-3D.
3DIMENSIONS Mammography System
- UDI-DI
- 15420045510609
- 15420045510593
- 15420045510586
- 15420045510579
- 15420045510562
- 15420045510555
- 15420045510524
- 15420045510531
- 15420045510548
- Model code
- 3DM-SYS-INTL2D
- 3DM-SYS-INTL2D-MOB
- 3DM-SYS-INTL2D-NS
- 3DM-SYS-INTL3D
- 3DM-SYS-INTL3D-MOB
- 3DM-SYS-INTL3D-NS
- 3DM-SYS-STD
- 3DM-SYS-STD-MOB
- 3DM-SYS-STD-NS.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Hologic, IncMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98566
- Recall numbers
- Z-2167-2026 to Z-2168-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
