Selenia Dimensions ASY-08483Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045505629), received between Sep 7, 2017 and Oct 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P010025); 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.

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.

• MalfunctionOct 20, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) DURING A SELENIA DIMENSIONS PROCEDURE, IT WAS REPORTED THAT THEY ATTEMPT TO PUT THE ARM AT 90° IT SOMETIMES GOES TO 45°. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE RIGHT ROTATION SWITCH BROKEN CAUSING UNCOMMANDED ROTATION WHEN C-ARM IS ROTATED NEGATIVELY FROM ZERO. THE EQUIPMENT WAS REPAIRED AND THE EQUIPMENT MET THE MANUFACTURER´S SPECIFICATIONS. NO INJURY TO THE PATIENT OR STAFF REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981120 ↗
• MalfunctionNov 20, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED THAT THE SYSTEM FROZE WHEN TAKING AN IMAGE, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED TO BE A SOFTWARE ISSUE, AND A REBOOTING THE SYSTEM RESOLVED THE ISSUE.

  Patient problems: Not Applicable

  MAUDE report 7045666 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THEY WERE INTERMITTENTLY GETTING LINES IN THE IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE HV POWER SUPPLY NEEDED TO BE REPLACED. ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 6932063 ↗
• MalfunctionSep 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ONE IMAGE DID NOT PREVIEW AND WHEN THE SYSTEM WAS RESTARTED IT WOULDN'T TURN ON, THIS RESULTED IN THE ONE IMAGE BEING REPEATED. THE FE REPLACED THE COMPUTER.

  Patient problems: Not Applicable

  MAUDE report 6899827 ↗
• MalfunctionSep 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED BY THE CUSTOMER "CAN'T CLEAR THE GEN 25:11 ERROR AND AFTER REBOOT, SAW GEN 25:8 ERROR TOO" WHICH RESULTED IN THE NEED FOR AN ADDITIONAL EXPOSURE TO COMPLETE THE EXAM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHICH CONFIRMED X-RAY TUBE LARGE FILAMENT IS OPEN. THE FSE REPLACED X-RAY TUBE AND PERFORMED ALL NECESSARY CALIBRATIONS. SYSTEM PASSED ALL TESTS AND MEETS ALL MANUFACTURER'S SPECIFICATIONS.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6849850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010025. One submission often covers many models, so check the product and lot details in each record.

• Z-2167-2026 · Apr 8, 2026 · Open, Classified
  SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-
• Z-1700-2014 · May 13, 2014 · Terminated
  Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography
• Z-2301-2013 · Sep 6, 2013 · Terminated
  Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that ca
• Z-1546-2008 · Feb 28, 2008 · Terminated
  Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810