Selenia Dimensions ASY-07460Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15420045505605), received between Oct 12, 2017 and Jan 16, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AFTER TAKING AN IMAGE A BLUE SCREEN WAS SEEN AS WELL AS AN ERROR MESSAGE. THE IMAGE WAS LOST, WHICH REQUIRED THE PATIENT TO BE RE-EXPOSED. A REBOOT WAS COMPLETED, AND AFTER THE REBOOT THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7194756 ↗
• MalfunctionJan 9, 2018Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THEY WERE GETTING GRIDLINES ON PATIENT IMAGES, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE KV EDGE CALIBRATION WAS OFF. GENERATOR CALIBRATIONS WERE DONE, AND THEN THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7176230 ↗
• MalfunctionNov 17, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THEY WERE GETTING GRIDLINES IN THE IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE MULIPLIER DRAWER NEEDED TO BE REPLACED. ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7042604 ↗
• MalfunctionNov 15, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THEY WERE GETTING GRIDLINES IN THE IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE GRID ASSEMBLY NEEDED TO BE REPLACED. ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 7033936 ↗
• MalfunctionOct 18, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THEY WERE GETTING IMAGE CAPTURE ERRORS, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE GRID RETRACTION MOTOR WASN'T STRONG ENOUGH AND NEEDED REPLACED. ONCE THIS WAS DONE THE UNIT IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 6958634 ↗
• MalfunctionOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THERE ARE LINES IN IMAGE THAT CAUSED THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THESE ARE SYMMETRICAL GATE LINES AND THE ARRAY NEEDS TO BE REPLACED. ONCE THIS WAS DONE, THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: Not Applicable

  MAUDE report 6944745 ↗

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