3DimensionsRecalls & reported problems across all models

We found 9 models of 3Dimensions by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2022 and Sep 30, 2026 — classified as 2 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (61 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

3Dimensions recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 7 of these models · Recall details · FDA record ↗

2. Aug 19, 2024Open, Classified

   Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

   Z-3248-2024 · Root cause: Software design · Recall details · FDA record ↗

3. Jan 16, 2023Open, Classified

   C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

   Z-1144-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported 3Dimensions problems

3Dimensions models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• 3Dimensions 3DM-SYS-STD

  Digital breast tomosynthesis
  1 recall57 reports
• 3Dimensions 3DM-SYS-INTL3D

  Digital breast tomosynthesis
  1 recall5 reports
• 3Dimensions 3DM-SYS-INTL2D-MOB

  Digital breast tomosynthesis
  1 recall5 reports
• 3Dimensions ASY-10559

  Digital breast tomosynthesis
  1 recall0 reports
• 3Dimensions 3DM-SYS-STD-NS

  Digital breast tomosynthesis
  1 recall0 reports
• 3Dimensions 3DM-SYS-INTL3D-NS

  Digital breast tomosynthesis
  1 recall0 reports
• 3Dimensions 3DM-SYS-INTL3D-MOB

  Digital breast tomosynthesis
  1 recall0 reports
• 3Dimensions 3DM-SYS-INTL2D-NS

  Digital breast tomosynthesis
  1 recall0 reports
• 3Dimensions ASY-11748-CHD

  Digital breast tomosynthesis
  1 recall0 reports

Recent 3Dimensions adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Thermal Decomposition of Device; Device Emits Odor; Arcing

  It was reported that a Dimensions system displayed an error related to high voltage arc detected, during a quality control testing. The system remained nonoperational following a reboot. No patient or user impact was reported. During service evaluation, the field service engineer identified arcing of the high voltage cable inside the generator and found the cable to be burnt. The high-voltage cable was replaced. An unpleasant odor for the generator during operation was also reported. the x-ray tube and generator were subsequently replaced; however, intermittent errors persisted. Following the replacement of the resistor pack, the errors cleared. Required generator and automatic exposure control calibrations were completed, and the system was verified to be operating to manufacturer specifications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949312 ↗
• InjurySep 16, 2026Thermal Decomposition of Device

  The field engineer reported that while onsite for an unrelated repair, a burning odor was detected, and a DTC error code was present. The system was immediately powered down. Upon investigation, a burned-out chip was identified on the DTC board. The board was replaced, which resoled the error. The system was confirmed to be functioning properly following repair. No patient or user impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792898 ↗
• MalfunctionJul 20, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT DURING A 3DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE ON (b)(6) 2026, THE "C-ARM MOVED FROM 35 DEGREES TO 180 DEGREES WITH NO USER INPUT. "[THE]" PATIENT IN "[A]" WHEELCHAIR SUSTAINED A BRUISED ARM." ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING THE PATIENT'S STATUS, IN WHICH IT WAS REPORTED "THE PATIENT RECEIVED A LIGHT BRUISE ON HER ARM AND LEG. THE PATIENT DECLINED MEDICAL ATTENTION, AND NO FURTHER ACTION WAS TAKEN BY THE STAFF."A HOLOGIC FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE DEVICE AND DETERMINED "AFTER CHECKING THE LOGS IT WAS FOUND THAT THE LEFT C-ARM SWITCH WAS RESPONSIBLE FOR THE MOVEMENT THAT OCCURRED. SOME DEBRIS BUILDUP WAS ALSO FOUND UNDERNEATH THE ROTATIONAL SWITCH." THE FSE REPLACED BOTH C-ARM SWITCH BANKS, INSPECTED, TESTED AND CALIBRATED THE UNIT IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bruise/Contusion

  MAUDE report 25883513 ↗
• MalfunctionJun 12, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF A 3DIMENSIONS, THE C-ARM MOVED UNEXPECTEDLY DURING A PATIENT EXAM WHILE POSITIONED AT 90 DEGREES FOR A LEFT TRUE LATERAL TOMOSYNTHESIS EXPOSURE. THE USER SITE REPORTED THAT THE C-ARM SHIFTED FROM APPROXIMATELY 90 DEGREES TO 92 DEGREES WHILE THE PATIENT WAS IN COMPRESSION AND THAT THE MOVEMENT WAS VISIBLE. IT WAS REPORTED BY THE USER SITE THAT AFTER THE SHIFT OCCURRED, THE SYSTEM SHUT DOWN. NO PATIENT IMPACT OR INJURIES WERE REPORTED, AND EXAMS WERE COMPLETED IN ANOTHER ROOM. A HOLOGIC FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE DEVICE AND FOUND THAT THE C-ARM WAS MOVING SLIGHTLY DURING TOMOSYNTHESIS AT 90 DEGREES. THE FSE INSPECTED THE VERTICAL TRAVEL ASSEMBLY (VTA) AND REPORTED THAT NO LOOSE BOLTS OR VTA MOVEMENT WERE FOUND. THE FSE REPORTED THAT THE C-ARM BRAKES WERE STICKING DURING THE TOMOSYNTHESIS SWEEP AT 90 DEGREES, CAUSING THE SYSTEM TO SHUT DOWN. BOTH C-ARM BRAKES WERE REPLACED BY THE FSE, AND ALL REQUIRED CHECKS AND CALIBRATIONS WERE PERFORMED. FOLLOWING REPAIR, THE FSE REPORTED THAT NO ERRORS OCCURRED DURING TESTING AND THE SYSTEM WAS VERIFIED TO BE OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494133 ↗
• 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 ↗
• MalfunctionMay 15, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF A 3DIMENSIONS MAMMOGRAPHY SYSTEM, THE SYSTEM GENERATED AN ERROR THAT PERSISTED AFTER REBOOT. THE USER SITE ALSO REPORTED THAT WHILE POSITIONING THE C-ARM, THE GANTRY MOVED DOWNWARD ON ITS OWN. THE EVENT OCCURRED DURING A PATIENT EXAM. NO PATIENT OR USER INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE. DURING THE INVESTIGATION, THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND DETERMINED THAT THE LEFT FOOT SWITCH ASSOCIATED WITH C-ARM MOVEMENT WAS STICKING. BOTH FOOT SWITCHES WERE REPLACED AND FUNCTIONAL TESTING WAS PERFORMED. FOLLOWING THE REPAIR, THE SYSTEM WAS RETURNED TO SERVICE AND VERIFIED TO BE OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194727 ↗
• MalfunctionMay 9, 2026Noise, Audible

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF A 3DIMENSIONS MAMMOGRAPHY SYSTEM, AN UNUSUAL NOISE WAS HEARD DURING THE TOMOSYNTHESIS SWEEP. IT WAS REPORTED THAT THE EVENT OCCURRED DURING A PATIENT EXAM. THE CALLER REPORTING THE ISSUE WAS NOT THE TECHNOLOGIST OPERATING THE SYSTEM AND WAS UNABLE TO PROVIDE FURTHER DETAILS REGARDING THE NATURE OF THE NOISE. NO USER OR PATIENT INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND OBSERVED ABNORMAL NOISE AND VIBRATION DURING TOMOSYNTHESIS MOTION. UPON INSPECTION, THE FSE FOUND THAT TWO C-ARM ROTATION BOLTS WITHIN THE VERTICAL TRAVEL ASSEMBLY (VTA) WERE BROKEN. THE FSE REMOVED AND REPLACED THE VTA ASSEMBLY AND ASSOCIATED COMPONENTS AND REASSEMBLED THE SYSTEM. REQUIRED CALIBRATIONS AND QUALITY CONTROL TESTING WERE PERFORMED. FOLLOWING THE REPAIR, THE TOMOSYNTHESIS MOTION WAS VERIFIED AND THE SYSTEM WAS CONFIRMED TO BE OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131558 ↗
• MalfunctionMay 5, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6), 2026, DURING USE OF A 3DIMENSIONS MAMMOGRAPHY SYSTEM DURING A PATIENT EXAM, THE C-ARM HOME BUTTON INTERMITTENTLY DID NOT RETURN THE C-ARM TO THE HOME POSITION AND INSTEAD MOVED THE C-ARM TO THE 90-DEGREE LEFT POSITION. NO USER OR PATIENT INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND OBSERVED THAT THE C-ARM CONTINUED MOVING AFTER THE CONTROL SWITCH WAS RELEASED. THE FSE FOUND THAT A ROCKER SWITCH LOCATED AT THE BOTTOM OF THE C-ARM WAS STICKING. THE FSE REPLACED THE WORN C-ARM SWITCHES AND PERFORMED OPERATIONAL TESTING. FOLLOWING THE REPAIR, THE C-ARM RESPONDED APPROPRIATELY TO SWITCH COMMANDS AND STOPPED MOVING WHEN THE SWITCH WAS RELEASED. THE SYSTEM WAS VERIFIED TO BE OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084426 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A 3DIMENSIONS PATIENT EXAM ON (B)(6) 2026, A BROKEN BOLT ON THE ROTATIONAL WORM GEAR WAS DISCOVERED AND THE VERTICAL TRAVEL ASSEMBLY (VTA) NEEDED TO BE REPLACED. NO USER INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND OBSERVED THAT A VERTICAL TRAVEL ASSEMBLY (VTA) BOLT WAS ROTATING IN THE BACK OF THE VTA ASSEMBLY. THE FSE DISASSEMBLED THE DEVICE AND INSTALLED A NEW VTA ASSEMBLY. THE FSE PERFORMED MULTIPLE DEVICE CALIBRATIONS INCLUDING VTA MOTION, GEOMETRY, TUBE, X-RAY ALIGNMENT, AND LIFE FIELD ALIGNMENT CALIBRATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405914 ↗
• MalfunctionFeb 6, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT DURING A 3DIMENSIONS PATIENT EXAM ON (B)(6) 2026, THE GANTRY SHUTDOWN. NO USER OR PATIENT INJURY WAS REPORTED. HOLOGIC TECHNICAL SUPPORT REPORTED THAT THE USER PRESSED THE C-ARM DOWN SWITCH, BUT THE C-ARM CONTINUED TO DRIFT DOWN UNTIL THE VERTICAL TRAVEL ASSEMBLY (VTA) ERROR CODE WAS TRIGGERED FOR UN-COMMANDED MOVEMENT. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND FOUND THE HORSESHOE OF THE DRAG BRAKE WAS OFF THE DRAG BRAKE. THE FSE INSTALLED THE HORSESHOE PROPERLY, RETESTED THE DEVICE, AND VERIFIED THAT THE DEVICE NO LONGER ERRORS OUT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284838 ↗
• MalfunctionDec 29, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A 3 DIMENSIONS PATIENT EXAM ON (B)(6) 2025, THAT THE C-ARM OF THE DEVICE MOVED DOWN BY ITSELF. AN ERROR MESSAGE WAS DISPLAYED ON THE DEVICE, IN WHICH THE USER SITE WAS UNABLE TO CLEAR. NO PATIENT OR USER INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE 3 DIMENSIONS DEVICE AND OBSERVED THAT THE DEVICE WAS FUNCTIONING PROPERLY AND ADDITIONALLY WAS UNABLE TO DUPLICATE THE ADVERSE EVENT. THE FSE REPORTED THAT THE ERROR LOG OF THE DEVICE SHOWED THAT RIGHT FOOT SWITCH WAS STUCK. THE FSE REPLACED BOTH GANTRY FOOT SWITCHES, CONFIRMED THAT ALL SWITCHES WERE WORKING PROPERLY, AND VERIFIED THAT THE SYSTEM IS NOW OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907265 ↗
• MalfunctionSep 24, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT THE RIGHT PANEL C-ARM "UP AND DOWN" BUTTON IS STICKING ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM. THE USER REPORTS THAT WHEN ATTEMPTING TO MOVE THE C-ARM UP AND DOWN, IT ROTATES INSTEAD. IT IS REPORTED THAT THIS OCCURRED PRIOR TO A PATIENT EXAMINE AND NO PATIENT OR USER INJURY WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) REPORTS THAT THE CUSTOMER SITE HAS REQUESTED TO HAVE THIS ISSUE ADDRESSED AT THE NEXT PREVENTATIVE MAINTENANCE (PM). NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23134189 ↗
• InjurySep 9, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A 3DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2025, THE C-ARM LOWERED, WITHOUT COMMAND, ONTO THE PATIENT'S ABDOMEN AND LEG. IT IS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM. THE FSE PULLED SYSTEM LOGS AND INSPECTED THE C-ARM WIRING AND CIRCUITRY BUT WAS UNABLE TO IDENTIFY ANY FAULTS. ADDITIONALLY, THE FSE RAN SEVERAL CYCLES OF VERTICAL AND ROTATIONAL MOVEMENTS USING ALL BUTTONS AND FOOT PEDALS AND FOUND THE SYSTEM TO BE FUNCTIONING AS IT SHOULD. FURTHER, THE FSE COMPLETED ALL C-ARM AND VERTICAL TRAVEL ASSEMBLY (VTA) RELATED CALIBRATIONS SUCCESSFULLY. THE FSE REPLACED THE MECHANICAL VERTICAL DRAG BRAKE WITH AN ELECTROMAGNETIC BRAKE AND COMPLETED POST SERVICE CHECKS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23003660 ↗
• 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 ↗
• MalfunctionJul 17, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A 3 DIMENSIONS MAMMOGRAPHY SYSTEM QC, THE C-ARM DID NOT STOP AT THE INTENDED STOP POSITION OF 180 DEGREES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT AND FOUND THE C-ARM STUCK IN A +190-DEGREE POSITION AND WAS UNABLE TO ROTATE IT BACK. THE FSE MANUALLY ROTATED THE C-ARM BACK TO THE ZERO-DEGREE POSITION, CALIBRATED THE C-ARM ZERO POSITION AND TOMO MOTION, AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535005 ↗

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