Hologic, Inc: Digital Breast Tomosynthesis
Summary Hologic is recalling its 3DIMENSIONS MAMMOGRAPHY SYSTEM (various models) distributed nationwide because internal bolts in these devices have been reported to become loose, missing, or broken over time. The systems are used in medical facilities across the United States. This is a Class III recall, which means the defect could potentially affect device performance.
- Recalling firm
- Hologic, Inc
- Product
- 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 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.
- Reason
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Classification
- Class III
- 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/a4f050f2-7410-455b-8e39-a14b9cfd0a28