⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Hologic, Inc: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3D

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-04-08
Code info
"[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.
Product quantity
14837 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
98566
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