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U.S. Department of Health and Human Services

Class 2 Device Recall HOLOGIC 3DIMENSIONS MAMMOGRAPHY SYSTEM

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 Class 2 Device Recall HOLOGIC 3DIMENSIONS MAMMOGRAPHY SYSTEMsee related information
Date Initiated by FirmApril 08, 2026
Date PostedMay 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2168-2026
Recall Event ID 98566
PMA NumberP080003 
Product Classification Digital breast tomosynthesis - Product Code OTE
Product3DIMENSIONS 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.
Code Information "[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.
FEI Number 1000120743
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information ContactBreast Health Customer Support
+1-800-4429892
Manufacturer Reason
for Recall		Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
FDA Determined
Cause 2		Device Design
ActionOn April 8, 2026 URGENT FIELD SAFETY NOTICE letters were sent to customers. Customers were informed of implementing an updated recurring maintenance inspection for detecting loosened, missing, or broken bolts within the VTA. Hologic Service will reach out to schedule your service appointment and perform the required inspection. Following the initial inspection, recurring inspections are required to be conducted at least every 6 months to ensure continued safe/proper operation of the system. Future inspections will consist of torque and visual confirmation that all bolts are present and that there is no indication of loosening. Actions: You may continue to use your 3Dimensions or Selenia Dimensions for its intended use. If at any time during system operation, you observe unexpected C-Arm movement, please discontinue use and contact Hologic s Technical Support immediately. Report suspected device complaints and/or adverse events to Hologic and the FDA (contact details below). After initial inspection by Hologic, it is required to have the inspection performed at least every 6 months as well as the other defined maintenance and service activities which are critical for continued safe and effective operation of the Selenia Dimensions or 3Dimensions system. Forward this notice to anyone in your facility that needs to be informed. Post a copy of this notice in a visible area near the affected devices where operators can view for awareness and please keep a copy for your records.
Quantity in Commerce14837 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OTE
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