Selenia Dimensions SDM-SYS-6000-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 15420045510760), received between Nov 11, 2022 and Nov 26, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

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-2167-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionJun 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT JERKING WAS OBSERVED DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D PROCEDURE. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND LOOSE BOLTS WITHIN THE VTA ASSEMBLY. THE FIELD ENGINEER REPLACED THE VTA ASSEMBLY AND PERFORMED ALL RELATED CALIBRATIONS AND CHECKS ON THE SYSTEM. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131857 ↗
• MalfunctionApr 15, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2024, THE C-ARM ON A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D, MOVED WITHOUT COMMAND TO ITS LOWEST POSITION DURING A PROCEDURE. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE EQUIPMENT AND DETERMINED THAT THE FOOT SWITCH BECAME STUCK, CAUSING THE C-ARM TO MOVE DOWN. THE FIELD ENGINEER REPLACED BOTH FOOT SWITCHES AND HAND SWITCHES AND CONFIRMED THAT THE EQUIPMENT IS NOW FUNCTIONING AT MANUFACTURERS SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840356 ↗
• MalfunctionApr 3, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON JANUARY 23RD, 2025, JERKY TOMO MOTION WAS OBSERVED ON A SELENIA DIMENSIONS 3D. A FIELD ENGINEER ASSESSED THE MACHINE AND FOUND LOOSE TOMO BOLTS. DURING THE REPAIR AND REPLACEMENT OF THE BOLTS, IT WAS FOUND THAT ONE OF THE OLD BOLTS HAD BROKEN OFF WITHIN THE VERTICAL TRAVEL ASSEMBLY (VTA). AS A RESULT, THE VTA WAS REPLACED ENTIRELY. THE FIELD ENGINEER COMPLETED ALL NECESSARY REPAIRS AND CALIBRATIONS, AND THE DEVICE IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURERS SPECIFICATIONS. NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763314 ↗
• MalfunctionFeb 5, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON (B)(6) 2025, THE TECH REPORTED THAT THE UNIT WAS NOISY AND THAT SHE HEARD AN UNUSUAL NOISE FROM THE GANTRY AND THAT THE C-ARM MOVED PAST THE COMMANDED MOTION. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND COULDN´T REPLICATE THE ISSUE. THE FIELD ENGINEER GREASED THE PLASTIC ON TUBE COVERS AND TESTED WITH 10 COMBO SHOTS AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315557 ↗
• MalfunctionDec 26, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A SELENIA DIMENSIONS PROCEDURE THE CUSTOMER REPORTED THAT THE MACHINE WAS TURNING AROUND AND THAT THE MACHINE WAS NOT STOPPING. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT THE ROTATION SWITCH OF THE BOTTOM OF THE C-ARM WAS STICKING. THE SWITCH WAS REPLACED AND THE ROTATION FLAPPER ON THE BACK OF THE C-ARM. THE UNIT WAS TESTED AND THE SYSTEM WAS FUNCTIONING PER THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019586 ↗
• MalfunctionNov 8, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM WAS JERKING WHILE DOING TOMO EXPOSURES. A FIELD ENGINEER EXAMINED THE EQUIPMENT ON (B)(6) AND IT WAS DETERMINED THAT THE SCREWS BEHIND THE VTA ASSEMBLY WERE LOOSE, ENGINEER RETIGHTENED THEM AND ORDERED A NEW KIT FOR REPAIR. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY OR STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646017 ↗
• MalfunctionSep 6, 2024Vibration; Vibration

  IT WAS REPORTED THAT ON JULY 24, A SELENIA DIMENSION HAD A JERKY TOMO MOTION AND NOISE. A FIELD ENGINEER EXAMINED THE DEVICE AND FOUND THAT THE VTA BOLTS NEEDED TO BE REPLACED. THE FIELD ENGINEER TIGHTENED THE WORM GEAR AND VTA BOLTS. PERFORMED TOMO MOTION CALIBRATIONS AND TESTED FUNCTIONALITY. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162543 ↗
• MalfunctionSep 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON JULY 11TH THAT DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM WAS VIBRATING AND MAKIN AND ODD NOISE DURING TOMO SWEEP. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND APPLIED LUBRICATION TO TOMO ROLLER AND PERFORMED VTA WORK GEAR ADJUSTMENT. PERFORMED TOMO CALIBRATIONS. VTA SCREWS WERE RETIGHTENED. A SCHEDULED MAINTENANCE WAS PROGRAMED IN AUGUST IN WHICH ITS INTENDED TO REPLACED THE SCREWS PER FMI KIT. SYSTEM WAS OPERATING ACCORDING TO MANUFACTURER´S SPECIFICATIONS AND NO PATIENT INJURY OR STAFF WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140405 ↗
• MalfunctionAug 30, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON 5TH OF AUGUST 2024, CUSTOMER REPORTED AN INCIDENT WITH OUR SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM. IT WAS REPORTED THAT THE C-ARM STARTED MOVING VERTICALLY WITHOUT ANY COMMAND FROM THE USER. IT WAS ALSO REPORTED THAT VTA 29:17 ERROR WAS SHOWN ON THE SYSTEM. THE INCIDENT OCCURRED PRIOR TO PROCEDURE WITH NO PATIENT IN THE ROOM. NO INJURY WAS REPORTED TO THE USER/STAFF. A FIELD ENGINEER VISITED THE SITE TO EXAMINE THE SYSTEM. VTA 29:17 ERROR USUALLY APPEARS WHEN THE SYSTEM DETECTS A C-ARM¿S VERTICAL MOTION ISSUE. OUR HOLOGIC FIELD ENGINEER OBSERVED THAT WHEN RELEASING THE SWITCH TO MOVE THE C-ARM DOWN, THE C-ARM DID NOT STOP RIGHT AWAY (DID NOT STOP AS FAST AS EXPECTED). THE MOVEMENT OF THE C-ARM CONTINUED TO APPROXIMATIVELY 0,5CM WITHOUT COMMAND, TRIGGERING THE VTA 29:17 ERROR. OUR HOLOGIC FIELD ENGINEER CHECKED THE MECHANICAL PARTS OF THE VERTICAL TRAVEL ASSEMBLY (VTA) AND FOUND THAT A CLUTCH IS DEFECTIVE. THE CLUTCH PART NUMBER ASY-03665 IS DESIGNED AND MEANT TO PREVENT UNCOMMANDED MOTIONS OF THE C-ARM. OUR HOLOGIC FIELD ENGINEER CONFIRMED THE ROOT CAUSE OF THIS INCIDENT IS A DEFECTIVE CLUTCH. THE DEFECTIVE CLUTCH ASY-03665 HAS BEEN REPLACED. THE SYSTEM WAS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113113 ↗
• MalfunctionAug 22, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON AUGUST 1, THAT A SELENIA DIMENSION MOVED ON ITS OWN WHEN TRYING TO DO AN EXPOSURE. A FIELD ENGINEER EXAMINED THE DEVICE AND COULD NOT REPRODUCE THE ERROR BUT FOUND A MISSING JUMPER WIRE ON THE VTA CONTROL BOARD. THE FIELD ENGINEER ADDED THE MISSING JUMPER WIRE AND READJUST VOLTAGE AND TESTED FUNCTIONALITY. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042582 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON JULY 26 A FIELD ENGINEER EXAMINED A SELENIA DIMENSION AND FOUND THAT THE VTA BOLTS WERE LOOSE AND NEEDED TO BE REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022814 ↗
• MalfunctionJul 2, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON JUNE 18, A PATIENT HAD A MAMMOGRAPHY PROCEDURE AND WHEN THE PATIENT POSITIONED, THE PADDLE RELEASED, SHE WENT OVER TO THE GANTRY AND THE GANTRY C-ARM ROTATED A LITTLE WITHOUT TOUCHING THE SYSTEM AND LOST POWER WITH AN ERROR VTA 29:14. A FIELD ENGINEER EXAMINED THE DEVICE AND CHECKED ALL FUSES, CONNECTORS, AND CAN BUS CONNECTIONS BEHIND THE DETECTOR. REBOOTED THE UNIT AND CHECKED ALL SWITCH ASSEMBLIES FOR PROPER OPERATION. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660985 ↗
• MalfunctionJun 24, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6), DURING A SELENIA DIMENSIONS PROCEDURE AN UNCOMMANDED C-ARM MOTION WAS OBSERVED. NO PATIENT NOR STAFF INJURY REPORTED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE C-ARM ROTATION ROCKER SWITCH WAS DEFECTIVE. THE C-ARM ROTATION ROCKER SWITCH WAS REPLACED AND THE SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURERS SPECIFICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601226 ↗
• MalfunctionMay 28, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON MAY 9, DURING A BIOPSY PROCEDURE, THE C-ARM ROTATED ON ITS OWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE ROTATION SWITCH AT THE REAR OF THE GANTRY WAS STICKING, CAUSING UNCOMMANDED MOTION. THE FIELD ENGINEER REPLACED THE ROTATION HANDLE ON THE BOTTOM OF THE C ARM.THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405193 ↗
• MalfunctionMay 14, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA PROCEDURE ON (B)(6) 2024, THE TUBE KEPT ROTATING ALL THE WAY AROUND AND DID NOT STOP AT 0 DEGREES. NO PATIENT OR STAFF INJURY REPORTED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE SWITCHES WERE DEFECTIVE. LEFT AND RIGHT SWITCHES WERE REPLACED AND THE SYSTEM PASSED ALL TESTS AND MEETS THE MANUFACTURER´S SPECIFICATION'S. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310657 ↗
• MalfunctionFeb 23, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON JANUARY 29, THAT THE SELENIA DIMENSIONS C-ARM CONTINUES TO MOVE AFTER RELEASING THE ROTARY SWITCH. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE ROTARY SWITCH AT THE BACK OF THE C-ARM WAS STUCK INTERMITTENTLY. THE FIELD ENGINEER REPLACED THE ROTARY SWITCH AND TESTED IT. THE EQUIPMENT MET THE MANUFACTURER´S SPECIFICATIONS. NO INJURY TO THE PATIENT OR STAFF WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767811 ↗
• MalfunctionFeb 19, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA PROCEDURE ON (B)(6) 2024, THE C-ARM KEEPS ROTATING UPSIDE DOWN WHEN AUTO ROTATION IS SELECTED, THE C-ARM IS NOT STOPPING AT THE DETENT POSITION. THE EQUIPMENT WAS EXAMINED BY A FIELD ENGINEER AND REPLACED THE C-ARM TRANSITION AND CONTROL BOARD ANT THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731251 ↗
• MalfunctionFeb 14, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM CONTINUED TO ROTATED AFTER THE BUTTON HAD BEEN RELEASED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE C-ARM BUTTON WAS STICKING FOR WHICH IT WAS REPLACED AND THE SYMPTOMS DISAPPEARED. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705970 ↗

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,