Selenia Dimensions SDM-SYS-9000-2DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045510777), received between Aug 4, 2023 and Mar 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 4, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) A 2D DIMENSIONS PROCEDURE WAS PERFORMED, AND DURING THE PROCEDURE THE C-ARM LEFT SWITCH BANK WAS DISABLED, AND THE C-ARM RAN ALL THE WAY TO THE TOP OF THE RANGE BY ITSELF AND GOT STUCK. A FIELD ENGINEER EXAMINED THE DEVICE AND THE LEFT SIDE OF THE C-ARM SWITCH PANEL BUTTONS WERE STICKING, WHEN MOVING THE C-ARM UP IT DOESN'T RELEASE. THE SWITCH PANELS WERE REPLACED AND THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO INJURY TO THE PATIENT OR STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465323 ↗

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,