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.
Class II
- Recalling firm
- Hologic, Inc
- Reason for recall
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Distribution pattern
- US Nationwide distribution.
- State
- MA
- Status
- Ongoing
- Recall number
- Z-2168-2026
- Recall initiated
- April 8, 2026
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