3Dimensions 3DM-SYS-INTL2D-MOBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045510593), received between Jan 10, 2024 and May 21, 2026 — 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.

• MalfunctionMay 21, 2026Unintended System Motion

  REFERENCE NUMBER ASSIGNED BY NATIONAL COMPETENT AUTHORITY: (B)(4). ON (B)(6) 2026, OUR DISTRIBUTOR REPORTED AN ISSUE WITH A 3DIMENSIONS MAMMOGRAPHY SYSTEM. SPECIFICALLY, DURING A PATIENT EXAMINATION, THE RIGHT FOOTSWITCH USED TO LOWER THE C-ARM BECAME STUCK, CAUSING THE C-ARM TO CONTINUE MOVING DOWNWARD WITHOUT COMMAND. NO ERROR MESSAGES WERE GENERATED. THE MOTION COULD BE STOPPED MANUALLY BY THE OPERATOR. THE FIELD SERVICE ENGINEER CONFIRMED THAT THE UNCOMMANDED VERTICAL MOVEMENT WAS CAUSED BY THE DEFECTIVE FOOTSWITCH. NO PATIENT OR USER INJURIES WERE REPORTED. OUR HOLOGIC TECHNICAL SERVICE TEAM REVIEWED THE INCIDENT AND CONFIRMED THAT THE RIGHT FOOTSWITCH USED TO CONTROL THE VERTICAL C-ARM MOVEMENT WAS DEFECTIVE. THE DISTRIBUTOR¿S FIELD SERVICE ENGINEER REPLACED THE FOOTSWITCH ASSEMBLY. AFTER THIS INTERVENTION, THE SYSTEM STARTED TO OPERATE NORMALLY. OUR HOLOGIC TECHNICAL SERVICE TEAM HAS ADVISED THE DISTRIBUTOR TO CONTINUE MONITORING THE SYSTEM AND TO REPORT ANY RECURRENCE OF THE ISSUE. CONFIRMATION WILL BE PROVIDED IN THE FINAL VIGILANCE REPORT. IMDRF CODES: A0512, E2403, F26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250717 ↗
• MalfunctionAug 7, 2025Unintended System Motion; Unintended System Motion

  ON JULY 21, 2025, AN INCIDENT WAS REPORTED BY OUR CUSTOMER INVOLVING THE 3DIMENSIONS MAMMOGRAPHY SYSTEM. DURING A PATIENT SCREENING, THE OPERATOR ACTIVATED THE AUTOMATIC ROTATION FUNCTION OF THE C-ARM, WHICH THEN ROTATED BEYOND THE INTENDED 45-DEGREE LIMIT. NO ERROR MESSAGE WAS DISPLAYED AT THE TIME. ALTHOUGH THE MOVEMENT WAS UNEXPECTED, NO INJURY OCCURRED TO THE PATIENT OR MEDICAL STAFF. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE EQUIPMENT AND WAS UNABLE TO REPLICATE THE ISSUE. THE FSE REPORTS THERE WERE SEVERAL ERRORS IN THE SYSTEM LOGS; THEREFORE, THE FSE COMPLETED AND UNSETUP/SETUP AND CLEARED THE SYSTEM DATABASE. THE FSE CHECKED THE C-ARM ROTATION AND FOUND NO ERRORS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743170 ↗
• MalfunctionFeb 4, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2025, THE CUSTOMER REPORTED THAT DURING A 3 DIMENSIONS PRIOR TO THE PROCEDURE THE C-ARM MOVED WITHOUT ANY ACTION PERFORMED BY THE USER. THE FOOTSWITCH WAS STUCK IN THE DOWN POSITION. THE CUSTOMER REPORTED A BURNING SMELL. NO INJURY TO THE PATIENT OR STAFF WAS REPORTED. NO PATIENT WAS AT THE ROOM AT THE TIME. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND REPLACED THE FOOTSWITCH WHICH RESOLVED THE ISSUE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305297 ↗
• MalfunctionApr 29, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), DURING A PROCEDURE THE C-ARM HAD AN UNCOMMANDED MOVEMENT. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THE C-ARM ROTATION SWITCH BEHIND THE DETECTOR WAS STICKING. THE FIELD ENGINEER REPLACED THE C-ARM ROTATION SWITCH, TESTED ALL C-ARM SWITCHES AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO OTHER INFORMATION IS AVAILABLE. NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209486 ↗
• MalfunctionJan 10, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), 2023 THE C-ARM WAS FOUND IN A LOW POSITION WHILE THE STAFF WERE OUTSIDE, AS IF IT MOVED DOWN ON ITS OWN. THE FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE FOOTSWITCH WAS STUCK, THE FIELD ENGINEER REPLACED THE FOOTSWITCH, AND THE DEVICE WAS TESTED AND PERFORMED AS EXPECTED. THE DEVICE IS WORKING AS THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489054 ↗

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,