Selenia Dimensions SDM-SYS-9000-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15420045510784), received between Mar 2, 2022 and Apr 1, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (14 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 18, 2026.

Recalls naming this device

1. Apr 8, 2026Class IIOpen, 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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 17, 2025Device Emits Odor; Unintended System Motion; Device Emits Odor; Unintended System Motion

  IT WAS REPORTED ON (B)(6) 2025, THAT A BURNING ODOR WAS NOTED DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D PROCEDURE. IT WAS ALSO REPORTED THAT WHEN THE C-ARM WAS BEING MOVED BY THE CUSTOMER USING THE LEFT C-ARM SWITCHES, THE C-ARM CONTINUED TO MOVE DOWN WITHOUT COMMAND AFTER THE SWITCH WAS RELEASED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND DETERMINE THAT THE ODOR AND THE CONTINUED C-ARM MOTION WERE DUE TO THE LEFT SIDE SWITCHES, WHICH HAD STOPPED WORKING. THE FIELD ENGINEER REPLACED BOTH THE LEFT AND RIGHT C-ARM SWITCHES AND CONFIRMED EQUIPMENT FUNCTIONALITY IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT OR USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859611 ↗
• MalfunctionJan 9, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA 3D DIMENSIONS PROCEDURE, THE CUSTOMER REPORTED THAT THE TOMO MOTION WAS STUTTERING, A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT SCREWS WERE LOOSE AFTER THE TOMO POT FAILURE. THE ROTATIONAL SCREWS WERE REPLACED AND RESOLVED THE ISSUE. 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 21112387 ↗
• MalfunctionNov 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON (B)(6) 2024, THE STAFF MOVED THE GANTRY BUT THE GANTRY KEPT MOVING DOWNWARD UNCONTROLLED UNTIL THE TECH HIT THE BUTTON AGAIN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT THE SIDE CONTROL PANEL NEEDED REPLACEMENT. THE RIGHT AND LEFT C-ARM CONTROL PANELS WERE REPLACED AND TESTED AND THE SYSTEM IS CURRENTLY OPERATING AND READY TO USE. NO PATIENT INJURY OR STAFF REPORTED. THE SYSTEM WAS WORKING PER MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605815 ↗
• InjuryJun 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON MAY 21, THE FACE SHIELD OF THE SYSTEM CRACKED DUE TO NORMAL USE AND THE MAMMOGRAPHY TECHNICIAN CUT HER HAND ON THE SHARP PLASTIC EDGES OF THE PLASTIC 3D MAMMO FACE SHIELD. THE TECHNICIAN DID NOT REQUIRE HOSPITALIZATION. A FIELD ENGINEER EXAMINED THE DEVICE AND CONFIRMED THAT THE FACE SHIELD WAS CRACKED AND REPLACED THE FACE SHIELD. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 19463264 ↗
• MalfunctionApr 29, 2024Break; Unintended System Motion; Break; Unintended System Motion

  IT WAS REPORTED THAT DURING A SELENIA DIMENSIONS PROCEDURE ON (B)(6) 2024, THE SYSTEM WAS SHAKING. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND THAT 3 OUT OF THE 8 BOLTS RELATED TO THE VTA ASSEMBLY HAD SHEARED OFF AND BROKE OFF. THE SYSTEM WAS SHUTDOWN AND THE PIECES WERE REPLACED. THE VTA GANTRY'S VERTICAL TRAVEL ASSEMBLY WAS REPLACED. AFTER REPLACEMENT THE SYSTEM PASSED TESTS AND MET THE MANUFACTURERS SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202483 ↗
• MalfunctionMar 20, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PROCEDURE ON FEBRUARY 4TH , THE SYSTEM GAVE A DATA ERROR AT 180 DEGREES DURING TOMO CALIBRATION. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND FOUND A BROKEN SCREW BROKEN ON THE ROTATION GEAR RELATED TO THE VTA ASSEMBLY. ALL THE SCREWS ON THE ROTATION GEAR WERE REPLACED AND A TOMO CALIBRATION WAS PERFORMED, THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY NOR STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946402 ↗
• MalfunctionDec 27, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SELENIA PROCEDURE THE C-ARM KEPT MOVING CONTINUOUSLY DUE TO THE SWITCHES STICKING. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS FOUND THAT THE SWITCHES NEEDED TO BE REPLACED. THE SWITCHES WERE REPLACED AND THE SYSTEM TESTED AND MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT OR STAFF INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398098 ↗
• MalfunctionMar 31, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A SELENIA DIMENSIONS PROCEDURE, THE C-ARM CONTINUE TO MOVE UNCOMMANDED WITHOUT ANY SWITCH BEING HELD DOWN. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE C-ARM BANK SWITCHES NEEDED TO BE REPLACED. THE SWITCHES WERE REPLACED AND NO FURTHER UNCOMMANDED MOTION OBSERVED. 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 16658994 ↗
• MalfunctionDec 16, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2022 , DURING A SELENIA DIMENSIONS PROCEDURE THE C- ARM CONTINUED TO ROTATE AFTER THE BUTTON WAS RELEASED. NO INJURIES REPORTED TO THE PATIENT OR STAFF. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND REPLACED THE C-ARM ROTARY SWITCH AND TESTED THE UNIT. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998655 ↗
• MalfunctionMay 25, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE C-ARM IS MOVING ON IT'S OWN. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE C-ARM SWITCH BANK WAS STUCK AT AN ANGLE. HE RESET THE SWITCH, AND ONCE THIS WAS COMPLETED THE SYSTEM WAS LEFT WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498197 ↗
• MalfunctionMar 2, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING CLEANING OF THE UNIT AFTER A PATIENT EXAM, THE USER PRESSED THE AUTO CORRECTION BUTTON AND THE UNIT CONTINUED MOTION TO -45 DEGREES. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE C-ARM SWITCHES AND ROTARY SWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655369 ↗

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,