3Dimensions 3DM-SYS-STDRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 15420045510524), received between Mar 11, 2022 and Sep 30, 2026 — classified as 2 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (51 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 25 most recent of 57 reports, 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 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 ↗
• 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 ↗
• MalfunctionJul 14, 2025Unintended System Motion; Unintended System Motion

  IT IS REPORTED THAT ON (B)(6) 2025, PRIOR TO A PATIENT EXAM, THE USER OBSERVED THE 3DIMENSIONS MAMMOGRAPHY SYSTEM ROTATE WITHOUT A VALID COMMAND. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE SYSTEM AND ATTEMPTED TO TROUBLESHOOT THE ISSUE BUT WAS UNABLE TO DUPLICATE WHAT THE USER REPORTED. THE SYSTEM LOGS: HOWEVER, INDICATED A POTENTIALLY STUCK ROTATION SWITCH, THEREFORE, THE ROTATION SWITCH WAS REPLACED. THE FIELD ENGINEER TESTED THE SYSTEM AND VERIFIED THAT IT IS WORKING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT/USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493744 ↗
• MalfunctionJul 7, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A 3DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE, THE C-ARM CONTINUED TO MOVE PAST THE INTENDED STOP POSITION. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND THAT A SWITCH ON THE C-ARM WAS STUCK, WHICH CAUSED THE UNCOMMANDED C-ARM MOTION. THE FIELD ENGINEER CLEANED AND LUBRICATED THE C-ARM ROTATION SWITCH, REPLACED WORN HARDWARE AND MADE ADJUSTMENTS TO PREVENT THE ROTATION SWITCH FROM RUBBING AGAINST THE FRAME OF THE C-ARM. THE FIELD ENGINEER CONFIRMED THAT THE SYSTEM IS NOW WORKING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420444 ↗
• MalfunctionJun 9, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A 3DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE, THE FOOT SWITCH BUTTON STUCK, CAUSING THE C-ARM TO MOVE DOWN AFTER THE BUTTON WAS RELEASED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND CONFIRMED THE CUSTOMERS REPORT. THE FIELD ENGINEER REPLACED THE FOOT SWITCH AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168461 ↗
• MalfunctionMay 23, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT THE RIGHT-SIDE SWITCHES ON A 3DIMENSION'S MAMMOGRAPHY SYSTEM WERE NOT WORKING. THE CUSTOMER ATTEMPTED SHUTTING OFF THE SYSTEM AND WIGGLING THE SWITCHES, BUT THE ISSUE CONTINUED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND DETERMINED THAT THE SWITCHES WERE INTERMITTENTLY NOT RESPONDING OR FOLLOWING WRONG COMMANDS. THE FIELD ENGINEER REPLACED THE C-ARM SWITCHES, TESTED ALL SWITCH SYSTEM FUNCTIONS AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH THE MANUFACTURERS SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079203 ↗
• MalfunctionMay 20, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT THE C-ARM ROTATION SWITCH ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM, IS CAUSING THE C-ARM TO MOVE WITHOUT COMMAND PAST THE INTENDED POSITION. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND CONFIRMED THE REPORTED ISSUE. THE FIELD ENGINEER ADJUSTED THE CLEARANCE ON THE SWITCH, ALLOWING IT TO MOVE FREELY, WHICH RESOLVED THE ISSUE. THE FIELD ENGINEER CONFIRMED THAT THE SYSTEM IS NOW OPERATING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056194 ↗
• MalfunctionMay 2, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2025, A CUSTOMER EXPERIENCED ERROR CODES ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM CAUSING THE SYSTEM TO SHUT DOWN. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND THE ERROR CODES WERE CAUSED BY THE C-ARM CONTINUING TO MOVE AFTER THE C-ARM SIDE SWITCH WAS RELEASED, CAUSING UNCOMMANDED C-ARM MOTION. THE FIELD ENGINEER REPLACED A SYSTEM BRAKE AS WELL AS THE C-ARM SWITCHES. THE FIELD ENGINEER TESTED THE SYSTEM TO ENSURE THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954207 ↗
• MalfunctionMay 1, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON APRIL 10TH, 2025, THAT THE C-ARM ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM BEGAN TO MOVE IN A DOWNWARD MOTION WITHOUT COMMAND. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND DETERMINED THAT THE UNCOMMANDED C-ARM MOTION WAS DUE TO A STUCK LEFT FOOT SWITCH. THE FIELD ENGINEER REPLACED THE LEFT FOOT SWITCH AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943196 ↗
• MalfunctionApr 28, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A PROCEDURE, THE C-ARM ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM CONTINUED TO ROTATE AFTER THE SWITCH WAS RELEASED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE SYSTEM AND DETERMINED THAT THE UNCOMMANDED MOTION WAS DUE TO SWITCHES THAT NEED TO BE REPLACED. NO PATIENT OR USER INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917465 ↗
• MalfunctionApr 25, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A 3 DIMENSIONS PROCEDURE ON (B)(6) 2025, THE CUSTOMER REPORTED THAT THE VERTICAL POSITION WOULD MOVE ON ITS OWN, WITH OR WITHOUT USER. A FE EXAMINED THE EQUIPMENT AND COULD NOT DUPLICATE THE EXACT ISSUE. BOTH FOOTSWITCHES WERE REPLACED AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914631 ↗
• MalfunctionApr 25, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT A 3DIMENSIONS MAMMOGRAPHY SYSTEM MOVED WITHOUT COMMAND. NO PATIENT OR USER INJURY WAS REPORTED. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911298 ↗
• MalfunctionApr 23, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON APRIL 2ND, 2025 THAT THE ROTARY SWITCH ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM WAS STICKING CAUSING UNCOMMANDED SYSTEM MOTION. A FIELD ENGINEER EXAMINED THE SYSTEM AND DETERMINED THAT THE LOWER ROTARY SWITCH NEEDED TO BE REPLACED. THE FIELD ENGINEER COMPLETED THE REPLACEMENT OF THE ROTARY SWITCH AND CONFIRMED THAT THE SYSTEM IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894671 ↗
• MalfunctionApr 23, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT THE C-ARM ON A 3DIMENSIONS MAMMOGRAPHY SYSTEM CONTINUOUSLY MOVED IN A DOWNWARD MOTION WITHOUT COMMAND. A FIELD ENGINEER WAS DISPATCHED AND EXAMINED THE EQUIPMENT, FINDING THAT A STUCK FOOT PEDAL SWITCH WAS THE CAUSE OF THE UNCOMMANDED SYSTEM MOTION. THE FIELD ENGINEER REPLACED THE FOOT PEDALS ON THE SYSTEM AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT/USER INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890752 ↗

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,