Selenia DimensionsRecalls & reported problems across all models

We found 9 models of Selenia Dimensions by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 245 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Apr 1, 2026 — classified as 6 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (85 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

Selenia Dimensions 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-2167-2026 · Root cause: Device Design · names 5 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 Selenia Dimensions problems

Selenia Dimensions models

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

• Selenia Dimensions ASY-04160

  Full field digital,system,x-ray,mammographic
  2 recalls47 reports
• Selenia Dimensions ASY-01966

  Full field digital,system,x-ray,mammographic
  131 reports
• Selenia Dimensions SDM-SYS-6000-3D

  Digital breast tomosynthesis
  1 recall29 reports
• Selenia Dimensions SDM-SYS-9000-3D

  Digital breast tomosynthesis
  1 recall16 reports
• Selenia Dimensions SDM-SYS-6000-2D

  Digital breast tomosynthesis
  1 recall5 reports
• Selenia Dimensions SDA-SYS-3000-2D

  Digital breast tomosynthesis
  1 recall4 reports
• Selenia Dimensions SDM-SYS-9000-2D

  Digital breast tomosynthesis
  1 recall2 reports
• Selenia Dimensions ASY-07460

  Full field digital,system,x-ray,mammographic
  6 reports
• Selenia Dimensions ASY-08483

  Full field digital,system,x-ray,mammographic
  5 reports

Recent Selenia Dimensions adverse event reports

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

• MalfunctionApr 1, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D PROCEDURE ON (B)(6) 2026, AN ERROR APPEARED WHEN ROTATING THE C-ARM AND IT CONTINUED TO ROTATE ALL THE WAY AROUND UNTIL IT WAS UPSIDE DOWN. THE USER SITE REPORTED THAT THE ISSUE WAS RESOLVED AT THE SITE BY RESTARTING THE GANTRY, AFTER WHICH THE SYSTEM FUNCTIONED NORMALLY. NO USER OR PATIENT INJURIES WERE REPORTED. HOLOGIC TECHNICAL SUPPORT ADVISED THE USER TO PRESS THE BUTTON FIRMLY SEVERAL TIMES AND TO WIGGLE IT TO HELP DISLODGE ANY DUST OR DEBRIS THAT MIGHT HAVE CAUSED IT TO STICK. THE CUSTOMER REPORTED THAT NO FURTHER EVENTS OCCURRED AFTER THE BUTTONS WERE ADJUSTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761011 ↗
• MalfunctionMar 30, 2026Unintended System Motion

  IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2026 THAT THE COMPRESSION DEVICE WAS NOT MOVING SMOOTHLY, WITH ¿ROUGH¿ MOTORISED COMPRESSION NOTED. THE USER SITE REPORTED THAT LOOSENESS WAS FOUND BY AN ENGINEER DURING A PREVIOUS VISIT TO THE SITE. NO USER OR PATIENT INJURIES WERE REPORTED. A (HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND OBSERVED THAT THE GEAR MOTOR ASSEMBLY HAD RUSTED AND WAS SLIPPING, THEN REPLACED THE GEAR MOTOR ASSEMBLY AND COMPRESSION THICKNESS POTENTIOMETER, RESET CDI DEFAULTS, AND PERFORMED ALL COMPRESSION CALIBRATIONS. THE FSE CONFIRMED MOTOR COMPRESSION WAS SMOOTH AND COMPRESSION THICKNESS ACCURATE FOR NORMAL 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 24722786 ↗
• MalfunctionDec 8, 2025Unintended System Motion; Unintended System Motion

  THE USER SITE REPORTED THAT ON (B)(6) 2025, PRIOR TO A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE, THAT THE DEVICE GENERATED AN ERROR CODE DURING USE. NO PATIENT OR USER INJURY WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND CHECK THE ERROR CODE. THE FSE FOUND THAT UPON REVIEWING THE MOVEMENT GRAPH OF THE DEVICE, IT WAS OBSERVED THAT THE C-ARM PERFORMED VERTICAL MOVEMENTS WITHOUT RECEIVING ANY COMMANDS. THE FSE FOUND THAT THE ISSUE WAS TRACED TO A MALFUNCTION IN THE MOTOR CLUTCH, WHICH WAS SUBSEQUENTLY REPLACED. THE FSE TESTED THE DEVICE AND VERIFIED THAT THE DEVICE IS NOW OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752609 ↗
• MalfunctionNov 26, 2025Unintended System Motion; Unintended System Motion

  THE USER SITE REPORTED THAT THE C-ARM OF A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D SYSTEM ROTATED ON ITS OWN PRIOR TO A PATIENT EXAM ON (B)(6), 2025. NO PATIENT OR USER INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE SYSTEM. THE USER SITE INFORMED THE FSE THAT THE C-ARM OF THE SYSTEM MOVED ON ITS OWN WHEN THE ROTARY SWITCH AT THE BOTTOM OF THE C-ARM WAS USED. THE FSE OBSERVED THAT THE ROTARY SWITCH OF THE SYSTEM IN THE BACK OF THE GANTRY WAS GETTING STUCK, WHICH CAUSED THE C-ARM TO MOVE ON ITS OWN. THE FSE ORDERED A NEW ROTARY SWITCH FOR THE SYSTEM. THE FSE REPLACED THE ROTARY SWITCH AND TESTED SYSTEM AND CONFIRMED THE SWITCH WAS NO LONGER GETTING STUCK. THE FSE PERFORMED GAIN CALIBRATION AND ARTIFACT EVALUATION 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 23658898 ↗
• MalfunctionOct 2, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT AFTER A SELENIA DIMENSIONS 3D MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2025, THE C-ARM ROTATED ON ITS OWN. NO PATIENT OR USER IMPACT WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE. THE FSE REPORTED THAT WHILE ONSITE, THE C ARM DID NOT ROTATE ON ITS OWN AND THAT THE C-ARM SWITCHES WERE NOT CONSISTENTLY RESPONSIVE. THE FSE IDENTIFIED THAT THE SYSTEM SWITCHES WERE NOT FUNCTIONING INTERMITTENTLY. THE FSE ASSESSED POTENTIAL WEAR AND TEAR ON THE SWITCHES AND DETERMINED THAT A REPLACEMENT FOR THE C-ARM SWITCHES WAS NECESSARY. THE FSE COMPLETED THE REPLACEMENT OF THE C-ARM SWITCHES AND PERFORMED CALIBRATION AND ARTIFACT EVALUATION TESTING. THE FSE REPORTED THE C-ARM WAS RESPONDING TO EACH SWITCH ONCE THE C-ARM SWITCHES WERE REPLACED. THE FSE 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 23200357 ↗
• InjurySep 24, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PATIENT PROCEDURE ON (B)(6), 2025, THE UNIT LOWERED ITSELF WITHOUT COMMAND. THE CUSTOMER REPORTS THAT WHILE POSITIONING THE PATIENT WHO WAS REPORTED TO BE IN A WHEELCHAIR, THE UNIT LOWERED, AND IT BROKE THE PATIENT'S ANKLE. THE CUSTOMER DENIES OBSERVING ANY ERROR CODES ON THE SYSTEM AT THE TIME OF THE REPORTED EVENT. NO FURTHER INFORMATION REGARDING THE PATIENT STATUS IS AVAILABLE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM. THE FSE TESTED ALL OF THE SWITCHES ON BOTH FOOT PEDALS, INCLUDING THE C-ARM DOWN SWITCH AND WAS UNABLE TO FIND ANY TO BE FAULTY. ADDITIONALLY, THE FSE CHECKED THE VERTICAL DRAG BRAKE, WHICH IS INSTALLED ON THE SYSTEM AND FOUND IT TO BE WORKING AS INTENDED. THE FSE ALSO COMPLETED SEVERAL C-ARM UP/DOWN CYCLES WITH NO ISSUES. THE FSE IN CONJUNCTION WITH HOLOGIC TECHNICAL SUPPORT REMOTED INTO THE SYSTEM TO REVIEW THE LOG FILES AROUND THE REPORTED TIME OF THE INCIDENT AND AGAIN, NO ISSUES WERE FOUND. TESTING OF THE DEVICE AND REVIEW OF SYSTEM LOGS FOUND NO ISSUES WITH THE DEVICE, AND IT IS REPORTED TO BE FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION

  Patient problems: Bone Fracture(s)

  MAUDE report 23133794 ↗
• MalfunctionSep 12, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS, 3D MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2025, THE C-ARM TURNED UPSIDE DOWN ON ITS OWN. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND DETERMINED THAT THE BOTTOM C-ARM SWITCH NEEDED TO BE REPLACED. THE FSE REPLACED AND TESTED THE BOTTOM C-ARM SWITCH AND CONFIRMED THAT NO UNCOMMANDED MOTION WAS OBSERVED. THE FSE REPORTS THAT THE SYSTEM IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040505 ↗
• MalfunctionSep 4, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT PRIOR TO A PATIENT EXAM ON (B)(6) 2025, THE RIGHT-SIDE GANTRY FUNCTION BUTTONS ON A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM WERE INTERMITTENTLY STICKING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE DEVICE AND CONFIRMED THE REPORTED FINDINGS. THE FSE REPLACED THE LEFT AND RIGHT GANTRY FUNCTION KEY PANELS, VERIFIED ALL GANTRY FUNCTION CONTROL BUTTONS RESPOND AS EXPECTED AND THAT THE FLAT FIELD COMBO IMAGE WORKED AS EXPECTED. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967203 ↗
• MalfunctionAug 7, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE, ON (B)(6) 2025, THE TUBE SPUN AROUND TO THE 170-DEGREE POSITION ON ITS OWN AND HIT THE TECHNICIAN ON THE HEAD. IT IS REPORTED THAT THE TECHNICIAN COMPLAINED OF A "SLIGHT HEADACHE" ON THE DAY OF THE EVENT BUT DID NOT NEED MEDICAL ATTENTION. IT IS REPORTED THAT THE CUSTOMER SITE MANAGER FOLLOWED UP WITH THE TECHNICIAN THE NEXT DAY AND THE TECHNICIAN "WAS GOOD." A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE EQUIPMENT AND FOUND THE ROTATIONAL SWITCH BEHIND THE DETECTOR WAS STUCK IN THE ENGAGED POSITION. THE FSE REPLACED THE ROTATIONAL SWITCH, VERIFIED THAT THE REPAIR CORRECTED THE ISSUE AND CONFIRMED THAT THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Headache

  MAUDE report 22742980 ↗
• MalfunctionJul 28, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING C-ARM CALIBRATION, THE C-ARM POSITION DESCENDED FROM -90 DEGREES TO -104 DEGREES AFTER THE TOMO BRAKE WAS RELEASED. IT IS REPORTED THAT THE C-ARM COULD BE MANIPULATED BY PUSHING WITH LITTLE FORCE. A SERVICE ENGINEER REPORTS THAT THE UPPER AND LOWER C-ARM BRAKE WAS REPLACED WHICH RESOLVED THE ISSUE. NO PATIENT/USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630160 ↗
• MalfunctionJul 17, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS 3D PATIENT PROCEDURE ON (B)(6) 2025, THE C-ARM CONTINUED TO MOVE IN A DOWNWARD MOTION AFTER THE FOOT PEDAL WAS RELEASED BY THE USER. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE SYSTEM AND CONFIRMED THE USER'S OBSERVATION. THE FIELD ENGINEER REPLACED THE FOOT PEDAL AND CONFIRMED THAT THE SYSTEM IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT/USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532306 ↗
• MalfunctionJul 7, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS 3D MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2025, THE USER RECEIVED SEVERAL SYSTEM ERRORS, AND THE UNIT SHUT DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND LOOSE SCREWS WITHIN THE VTA ASSEMBLY, WHICH PREVENTED THE SYSTEM BRAKE FROM FUNCTIONING PROPERLY. THE FSE REMOVED THE LOOSE SCREWS, APPLIED LOCTITE TO THE THREADS AND REINSTALLED THE SCREWS. THE FSE TESTED THE SYSTEM AND CONFIRMED THAT NO ADDITIONAL ERRORS WERE DISPLAYED. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418058 ↗
• MalfunctionJun 16, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE ON (B)(6) 2025, THE USER WAS UTILIZING A SWITCH ON THE UNIT TO ROTATE THE C-ARM AND THE C-ARM CONTINUED ROTATING AFTER THE SWITCH WAS RELEASED. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE UNIT, ORDERED NEW C-ARM SWITCHES AND INSTALLED THE NEW SWITCHES ON THE SYSTEM. THE FIELD ENGINEER INDICATES THAT THE SYSTEM IS NOW WORKING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214174 ↗
• MalfunctionJun 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON MAY 9TH, 2025, THAT THE C-ARM ON A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D WAS MAKING NOISE AND SHAKING WHEN TURNED TO THE LEFT. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND LOOSE BOLTS WITHIN THE VTA ASSEMBLY. THE FIELD ENGINEER REMOVED EACH BOLT, APPLIED LOCTITE AND RETIGHTENED THE BOLTS. THE FIELD ENGINEER COMPLETED SYSTEM CALIBRATIONS AND VERIFIED 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 22132785 ↗
• MalfunctionJun 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT SYSTEM SHAKING WAS OBSERVED DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D PROCEDURE. A FIELD ENGINEER WAS DISPATCHED AND FOUND LOOSE BOLTS WITHIN THE SYSTEM. THE FIELD ENGINEER REPLACED THE LOOSE HARDWARE, COMPLETED SYSTEM CALIBRATIONS AND CONFIRMED THAT THE SYSTEM IS OPERATING TO MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132688 ↗

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