Hologic, Inc: Full Field Digital, System, X-ray, Mammographic
Recall Summary Hologic is recalling multiple models of Selenia Dimensions mammography systems used across the United States because internal bolts can become loose, missing, or broken over time. This is a Class II recall, meaning the problem could potentially affect the system's performance. The recall affects medical facilities nationwide that use these mammography devices.
- Recalling firm
- Hologic, Inc
- Product
- SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: 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.
- Reason
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7c75afc5-aad8-485f-aa7d-1f6ffcdbaa8d