3Dimensions 3DM-SYS-INTL3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045510579), received between Jun 24, 2024 and Jun 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (P080003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 8, 2026Open, Classified

   Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

   Z-2168-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT THE LEFT C-ARM SIDE PANEL BUTTONS INTERMITTENTLY DO NOT WORK ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE EQUIPMENT AND FOUND THAT THE SWITCHES WOULD STICK, CAUSING UNCOMMANDED C-ARM MOTION. THE FIELD ENGINEER ORDERED NEW SWITCHES AND INDICATED THAT THEY WOULD BE INSTALLED WITH HOLOGIC TRAINED BIOMED UPON ARRIVAL. THE FIELD ENGINEER INDICATED THAT THE PROBLEM HAS NOW BEEN RESOLVED. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124320 ↗
• MalfunctionDec 24, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A 3DIMENSIONS PROCEDURE ON (B)(6) 2024, WHEN MOVING THE C-ARM TO 90° ANGLE, IT WAS REPORTED THAT THE C-ARM WAS RANDOMLY OVER ROTATING TO 92° WITHOUT ANY TYPE OF COMMAND. ERROR MESSAGE/CODE VTA (29:14) WAS DISPLAYED DURING THE INCIDENT (ISSUED WHEN THE MEASURED CARM/TOMO MOTION IS SLOW OR IN THE WRONG DIRECTION). THE INCIDENT OCCURRED PRIOR PROCEDURE WITH NO PATIENT IN THE ROOM. NO INJURY WAS REPORTED TO THE USER/STAFF. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT THE ERROR COULD NOT BE REPRODUCED BUT THE ROT POTENTIOMETER WAS REPLACED AND THE BRAKES WERE ADDITIONALLY REPLACED AND THE ANTI-BACKLASH BRAKE PLATES. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011459 ↗
• MalfunctionNov 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON THE (B)(6) 2024, OUR DEALER REPORTED AN INCIDENT WITH OUR 3DIMENSIONS MAMMOGRAPHY SYSTEM. IT WAS REPORTED THAT THE SYSTEM SHUT DOWN WHILE USING. DEALER ALSO REPORTED THAT SOME ERROR CODES WERE DISPLAYED. ON 10TH OF OCTOBER 2024, OUR HOLOGIC TECHNICAL SERVICE REVIEWED LOGS AND VIDEO PROVIDED BY THE DEALER. FROM THE LOGS, IT WAS CONFIRMED THAT ERROR CODE VTA 29:17 APPEARED AT THE TIME OF THE INCIDENT. THIS ERROR CODE VTA 29:17 IS TRIGGERED WHEN AN UNCOMMANDED VERTICAL MOTION OF THE C-ARM IS DETECTED. FROM A VIDEO, OUR HOLOGIC TECHNICAL SERVICE COULD CONFIRM THAT THE C-ARM SLIGHTLY MOVED DOWNWARDS, POTENTIALLY DUE TO THE BRAKE NOT ENGAGING. THE INCIDENT OCCURRED BEFORE PROCEDURE WITHOUT PATIENT IN THE ROOM. NO INJURY WAS REPORTED TO THE USER/STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604353 ↗
• MalfunctionAug 30, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON AUGUST 14, WHEN THE RADIOLOGIST PRESSED THE C-ARM MOTION REQUEST OF THE SELENIA DIMENSION, THE MOVEMENT WAS SLIGHTLY IN THE OPPOSITE DIRECTION THAN WHAT WAS REQUESTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112922 ↗
• MalfunctionJun 24, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6), THAT A 3DIMENSIONS WAS MOVING BY ITSELF DUE TO A SWITCH GETTING STUCK. THE FIELD ENGINEER EXAMINED THE DEVICE AND FOUND THAT A ROTARY SWITCH MIGHT HAVE MECHANICAL ISSUE. THE FIELD ENGINEER REPLACED THE DEFECTIVE SWITCH AND TESTED FUNCTIONALITY. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080003. One submission often covers many models, so check the product and lot details in each record.

• Z-3248-2024 · Aug 19, 2024 · Open, Classified
  Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824
• Z-1144-2023 · Jan 16, 2023 · Open, Classified
  Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-
• Z-1343-2020 · Jan 21, 2020 · Terminated
  Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,