Selenia Dimensions SDM-SYS-6000-2DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045510753), received between Mar 8, 2022 and Jun 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (4 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. 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-2167-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 13, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON APRIL 16, DURING A PROCEDURE THE C-ARM MOVED INTERMITTENTLY WHEN THE SYSTEM WAS IN LATERAL POSITION WHEN THE TUBE HEAD WAS ON THE LEFT SIDE. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND WAS UNABLE TO REPRODUCE THE FAILURE MODE. THE FIELD ENGINEER REPLACED THE VERTICAL DRAG BRAKE AND CONFIRMED THAT THE BACKLASH MEASUREMENTS ON THE MAIN GEAR WERE PASSING. THE SYSTEM IS FUNCTIONING PROPERLY AND MEETS ALL MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305793 ↗
• MalfunctionFeb 15, 2024Unintended System Motion; Unintended System Motion

  PENDING RESULTS OF INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712815 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING A PREVENTIVE MAINTENANCE FOR A SELENIA DIMENSIONS 2D ON (B)(6) 2023, A BROKEN BOLT FROM THE VTA ASSEMBLY WAS FOUND. THE FIELD ENGINEER REPLACED THE VTA ASSEMBLY PER PROCEDURES AND THE SERVICE MANUAL AND PERFORMED ALL REQUIRED CALIBRATIONS. ALL CALIBRATIONS AND TESTS PASSED AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO PATIENT INJURY OR STAFF REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674158 ↗
• MalfunctionMar 8, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE LEFT SIDE FOOT PEDAL SWITCH FOR VERTICAL TRAVEL WAS STICKING INTERMITTENTLY. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOT PEDAL NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695882 ↗

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,