Selenia Dimensions 3D System 3D softwareRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15420045500013), received between Nov 18, 2015 and Apr 4, 2023 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (2 reports).

4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON (B)(6), THE FOOT PEDAL ON THE LEFT SIDE OF THE GANTRY KEPT GOING AND THE C-ARM DID NOT STOP MOVING. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE FOOT SWITCH WAS STUCK AND THE C-ARM MOVES DOWN AFTER THE SWITCH WAS RELEASED. THE LEFT FOOT SWITCH WAS REPLACED AND THE C-ARM WAS WORKING CORRECTLY. SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674610 ↗
• InjuryJun 13, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016 ONE PATIENT FELL WHEN BEING RELEASED FROM COMPRESSION THE PATIENT FELL BACKWARD AGAINST THE CONTROL PANEL AND INTO THE WALL BY THE STORED COMPRESSION PADDLES. AFER THE PATIENT HAD FALLEN SHE TOLD THE TECHNICIAN SHE WASN'T FEELING WELL THAT MORNING AND TOOK HER BLOOD PRESSURE MEDICINE. THEY EVALUATED THE PATIENT WHO HAD SCRAPPED HER ELBOW AND HAD A HEADACHE. THE TOOK HER BLOOD PRESSURE WHICH WAS 150/90. THE PATIENT WAS SENT TO THE ER WHERE THEY DIAGNOSED A BRAIN BLEED, BUT COULDN'T SAY WHETHER THE FALL CAUSED IT. (B)(6) THE INTERIM RADIOLOGY MANAGER DIDN'T HAVE ANY FURTHER DETAILS AND THE SAME FOR FOLLOW-UP ON THE PATIENT. THERE WAS ANOTHER INCIDENT SOME TIME IN (B)(6) DID NOT KNOW EXACTLY WHEN. OR MANY OF THE DETAILS. THE PATIENT WAS IN COMPRESSION AND HAD A BIGGER STOMACH, WITH HER FACE UP AGAINST THE FACE SHIELD AND DUE TO HER LARGER STOMACH THEY HAD TO ADJUST HER STOMACH TO GET HER BREAST UP ONTO THE DETECTOR. WHEN COMPRESSION RELEASED SHE FELL BACK AND THE TECH WAS ABLE TO GET TO HER AS SHE WAS FALLING AND GUIDED HER TO THE FLOOR. (B)(6) SPOKE TO THE PATIENT WHO WAS UNHURT AND HAD NO PAIN. SHE ALSO SAID SHE HAD NO NEW BACK PAIN. (B)(6) IS NOT SURE ABOUT ANY FOLLO

  Patient problems: Fall; Headache

  MAUDE report 6638342 ↗
• InjuryJun 13, 2017Device Handling Problem; Device Handling Problem

  A CABINET HAD BEEN PLACED IN THE MAMMOGRAPHY ROOM, WHICH PREVENTED THE C-ARM FROM MOVING TO 90 DEGREES. A TECHNOLOGIST AND HER MANAGER WERE TRYING TO MEASURE WHERE THE CABINET NEEDED TO BE CUT AND THE TECHNOLOGIST ANGLED THE C-ARM ONTO THE MANAGERS HAND. THE MANGER SUSTAINED A BROKEN FINGER AND PART OF THE FINGER STAYED ON THE CABINET REQUIRING A SKIN GRAPH.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 6638184 ↗
• MalfunctionAug 12, 2016Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  THIS MDR IS A RESUBMIT PER REQUEST OF (B)(6) WHICH WAS RECEIVED BY HOLOGIC, INC. ON (B)(6) 2020. DURING A STEREO BIOPSY THE TECHNOLOGIST CONFIRMED THE COORDINATES FOR THE NEEDLE POSITION, THEN PRESSED THE MOTOR ENABLE BUTTON TO MOVE THE NEEDLE TO THE TARGET, SHE SAID THE UNIT BEEPED VERY QUICKLY SO SHE RELEASED THE MOTOR ENABLE BUTTONS. THE TECHNOLOGIST THEN NUMBED THE PATIENT BREAST AND MADE AN INCISION. NEXT SHE WENT TO MANUALLY DIAL IN THE NEEDLE AND NOTICED IT WAS IN THE INCORRECT POSITION. THE TECHNOLOGIST THEN RETARGETED AND HELD THE MOTOR ENABLE BUTTON LONGER AND THE NEEDLE WENT TO THE CORRECT POSITION SO SHE THEN MADE A SECOND INCISION AND CONTINUED TO DO A SUCCESSFUL BIOPSY. A FE REVIEWED THE DEVICE LOGS AND DETERMINED IT WAS POSSIBLE USER ERROR OR SWITCHES GOING BAD. WHEN THE CUSTOMER RETARGETED AND RESET THE COORDINATES, THE MACHINE WORKED AS EXPECTED.

  Patient problems: Tissue Damage

  MAUDE report 5873705 ↗
• MalfunctionAug 9, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  ORIGINALLY ON (B)(6) 2016 REPORTED AS A SHAKING C-ARM. UPON FURTHER INVESTIGATION IT WAS REPORTED ON (B)(6) 2016 THAT 5 OF THE 6 TUBE ARM SCREWS WERE UNSCREWED. ALSO 16 SCREWS FROM THE INSIDE RAILS HAD COME ALMOST ENTIRELY UNSCREWED. THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5857614 ↗
• InjuryAug 4, 2016Unintended Arm Motion; Unintended Arm Motion

  THE RADIOGRAPHER HAD FINISHED HER SCREENING EXAM AND ROTATED THE C-ARM TO AN UPRIGHT POSITION USING THE SWITCH BEHIND THE DETECTOR, AND THEN REMOVED HER HAND FROM THE SWITCHES. WHEN SHE TURNED TO GET A WET WIPE TO CLEAN THE SYSTEM SHE WASN'T AWARE THAT THE ROTATION DIDN'T STOP BUT CONTINUED TO ROTATE AND IT HIT HER ON HER LEFT SHOULDER. THERE WAS ROOM FOR THE RADIOGRAPHER TO MOVE OUT OF THE WAY AS THE C-ARM CONTINUED ROTATING. WHEN IT STOPPED, IT DISPLAYED AN ERROR THAT THE SWITCH HAD FAILED. NO INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5848142 ↗
• MalfunctionJul 27, 2016Mechanical Problem; Mechanical Problem

  THE C-ARM WAS JERKY AS THE ARC WENT ACROSS PATIENT AS ROTATED AROUND, WITH PATIENT IN COMPRESSION. THERE WAS NO AFFECT IMAGE QUALITY, NOR WAS THERE ANY INJURY TO THE PATIENT. THIS HAS BEEN AN INTERMITTENT PROBLEM FOR A COUPLE OF WEEKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5828128 ↗
• MalfunctionJun 25, 2016Physical Property Issue; Physical Property Issue

  THE UNIT HAD JUST BEEN TURNED ON AND TECH WAS OUTSIDE THE ROOM WHEN HEARD THE NOISE AND FOUND THE X-RAY SHIELD HAD SHATTERED IN TO A MILLION PIECES. NO ONE WAS IN THE ROOM AT THE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5750087 ↗
• MalfunctionJun 11, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER BUMPED THE SMALL PADDLE AGAINST SOMETHING CREATING A SMALL SPACE IN THE FRONT OF THE PADDLE. THE PADDLE IS NOT IN USE.

  Patient problems: Not Applicable

  MAUDE report 5719351 ↗
• MalfunctionMay 25, 2016Unintended Arm Motion

  C-ARM LOWERED WITH PATIENT IN COMPRESSION. THE TECHNOLOGIST WAS IN THE PROCESS OF POSITIONING THE PATIENT WHEN THE C-ARM STARTED TO MOVE DOWN. THE TECHNOLOGIST MOVED THE PATIENT BACK OUT OF THE WAY. NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5680807 ↗
• InjuryMay 18, 2016Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016 ONE PATIENT FELL WHEN BEING RELEASED FROM COMPRESSION, THE PATIENT FELL BACKWARD AGAINST THE CONTROL PANEL AND INTO THE WALL BY THE STORED COMPRESSION PADDLES. AFER THE PATIENT HAD FALLEN, SHE TOLD THE TECHNICIAN SHE WASN'T FEELING WELL THAT MORNING AND TOOK HER BLOOD PRESSURE MEDICINE. THEY EVALUATED THE PATIENT WHO HAD SCRAPPED HER ELBOW AND HAD A HEADACHE. THE TOOK HER BLOOD PRESSURE WHICH WAS 150/90. THE PATIENT WAS SENT TO THE ER WHERE THEY DIAGNOSED A BRAIN BLEED, BUT COULDN'T SAY WHETHER THE FALL CAUSED IT. (B)(6), THE INTERIM RADIOLOGY MANGER DIDN'T HAVE ANY FURTHER DETAILS AND THE SAME FOR FOLLOW-UP ON THE PATIENT. THERE WAS ANOTHER INCIDENT SOME TIME IN (B)(6), (B)(6) DID NOT KNOW EXACTLY WHEN OR MANY OF THE DETAILS. THE PATIENT WAS IN COMPRESSION AND HAD A BIGGER STOMACH, WITH HER FACE UP AGAINST THE FACE SHIELD AND DUE TO HER LARGER STOMACH THEY HAD TO ADJUST HER STOMACH TO GET HER BREAST UP ONTO THE DETECTOR. WHEN COMPRESSION RELEASED, SHE FELL BACK AND THE TECH WAS ABLE TO GET TO HER AS SHE WAS FALLING AND GUIDED HER TO THE FLOOR. (B)(6) SPOKE TO THE PATIENT WHO WAS UNHURT AND HAD NO PAIN. SHE ALSO SAID SHE HAD NO NEW BACK PAIN. (B)(6) IS NOT SURE ABOUT

  Patient problems: Fall; Headache

  MAUDE report 5664689 ↗
• InjuryApr 29, 2016Device Handling Problem; Device Handling Problem

  A CABINET HAD BEEN PLACED IN THE MAMMOGRAPHY ROOM, WHICH PREVENTED THE C-ARM FROM MOVING TO 90 DEGREES. A TECHNOLOGIST AND HER MANAGER WERE TRYING TO MEASURE WHERE THE CABINET NEEDED TO BE CUT AND THE TECHNOLOGIST ANGLED THE C-ARM ONTO THE MANAGERS HAND. THE MANGER SUSTAINED A BROKEN FINGER AND PART OF THE FINGER STAYED ON THE CABINET REQUIRING A SKIN GRAPH.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 5619904 ↗
• InjuryNov 30, 2015Appropriate Device Problem Term/Code Not Available

  REPORTED BY MAMMOGRAPHY DEPARTMENT MANAGER, (B)(6). PATIENT HAD DIFFICULTY HOLDING ON TO 'GROOVES' ON DIMENSIONS SYSTEM, LOST HER BALANCE, FELL AND BROKE A HIP DURING ACQUISITION OF TOMO RCC ACQUISITION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 5254263 ↗
• MalfunctionNov 18, 2015Adverse Event Without Identified Device or Use Problem

  DURING A 4 EXPOSURE MAMMOGRAM, WHEN DOING THE 4TH EXPOSURE THE PATIENT SAID THAT THE UNIT WAS HOT AND BURNING HER. WHEN SHE WAS RELEASED FORM COMPRESSION THERE APPEARED A RED MARK ON HER RIGHT AXILLA. SHE WAS EXAMINED BY THE RADIOLOGIST BUT REFUSED ANY FURTHER MEDICAL ATTENTION. THE SITE FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND SHE SAID SHE WAS FINE. THE ROOM WAS SHUT DOWN.

  Patient problems: Burning Sensation

  MAUDE report 5233451 ↗

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-2168-2026 · Apr 8, 2026 · Open, Classified
  3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-ST
• 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,