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Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D
Recalled May 20, 2026 · FDA recall Z-2168-2026 · Hologic
Hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. · FDA Class II
Units
14837 units
Sold at
US Nationwide distribution.
Description
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
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.
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →