Selenia Dimensions SDA-SYS-3000-2DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15420045510616), received between Sep 17, 2024 and Dec 8, 2025 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Unintended System Motion; Unintended System Motion

  THE USER SITE REPORTED THAT ON (B)(6) 2025, PRIOR TO A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PROCEDURE, THAT THE DEVICE GENERATED AN ERROR CODE DURING USE. NO PATIENT OR USER INJURY WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND CHECK THE ERROR CODE. THE FSE FOUND THAT UPON REVIEWING THE MOVEMENT GRAPH OF THE DEVICE, IT WAS OBSERVED THAT THE C-ARM PERFORMED VERTICAL MOVEMENTS WITHOUT RECEIVING ANY COMMANDS. THE FSE FOUND THAT THE ISSUE WAS TRACED TO A MALFUNCTION IN THE MOTOR CLUTCH, WHICH WAS SUBSEQUENTLY REPLACED. THE FSE TESTED THE DEVICE AND VERIFIED THAT THE DEVICE IS NOW OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752609 ↗
• MalfunctionApr 18, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED ON APRIL 3RD, 2025, THAT A CUSTOMER RECEIVED AN ERROR CODE ON A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND THE C-ARM WAS MOVING DOWN WITHOUT COMMAND. THE FIELD ENGINEER DETERMINED THAT THE ISSUE WAS DUE TO A MALFUNCTIONING FOOT SWITCH. THE FIELD ENGINEER REPLACED THE FOOT SWITCH AND TESTED THE SYSTEM TO ENSURE IT IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO PATIENT/USER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865652 ↗
• MalfunctionJan 23, 2025Unintended System Motion; Unintended System Motion

  ON (B)(6) 2025, OUR CUSTOMER REPORTED AN INCIDENT WITH OUR SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM IN WHICH UNCOMMANDED MOTION WAS REPORTED. ON (B)(6) 2025, OUR FIELD SERVICE ENGINEER CONFIRMED THAT C-ARM MOVED IN AN IRREGULAR DOWNWARDS DIRECTION SLIGHTLY UP/DOWN DIRECTION WITHOUT ANY COMMAND. THE FIELD ENGINEER FOUND A DRY VTA SPINDLE AND SUCCESSFULLY CLEANED IT AND RE-GREASED ACCORDING TO MANUFACTURER´S SPECIFICATIONS. THE DEVICE MET THE MANUFACTURER´S SPECIFICATIONS. THE INCIDENT OCCURRED BEFORE THE PATIENT EXAM/PROCEDURE. NO INJURY WAS REPORTED TO THE USER/STAFF. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218189 ↗
• MalfunctionSep 17, 2024Unintended System Motion; Unintended System Motion

  ON THE 2ND OF SEPTEMBER 2024, OUR CUSTOMER REPORTED AN INCIDENT WITH OUR SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM. IT WAS REPORTED THAT A VTA 29:17 ON 2ND OF SEPTEMBER 2024, A FIELD SERVICE ENGINEER CONFIRMED THAT C-ARM MOVED SLIGHTLY UP/DOWN DIRECTION WITHOUT ANY COMMAND. THE INCIDENT OCCURRED DURING THE PROCEDURE. NO INJURY WAS REPORTED TO THE USER/STAFF. ON THE 2ND OF SEPTEMBER 2024, THE FIELD ENGINEER VISITED THE SITE TO EXAMINE THE SYSTEM FOR VTA 29:17 ERROR, CHECKED THE MECHANICAL PARTS OF THE VERTICAL TRAVEL ASSEMBLY (VTA), AND FOUND THAT THE MOTOR CLUTCH WAS DEFECTIVE. THE DEFECTIVE CLUTCH HAS BEEN REPLACED. THE SYSTEM WAS EXTENSIVELY TESTED AND IS NOW OPERATING ACCORDING TO SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237945 ↗

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,