Selenia FFDM ASY-00676Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045505940), received between Apr 14, 2022 and Jan 18, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (5 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.

• MalfunctionJan 18, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2022 , DURING A SELENIA DIMENSIONS PROCEDURE THE C-ARM WAS MOVING BY ITSELF. NO PATIENT OR STAFF INJURY REPORTED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE FOOT SWITCH WAS STUCK AN NEEDED TO BE REPLACED. THE SYSTEM MET THE MANUFACTURERS SPECIFICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195196 ↗
• MalfunctionJul 25, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT WHEN RELEASING THE COMPRESSION UP THE MACHINE WOULD MOVE DOWNWARD. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOT PEDAL CONNECTION WAS LOOSE. THE FOOT PEDAL PINS WERE REALIGNED AND CLEANED ALLOWING FOR THE PROPER CONNECTION TO BE MADE. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099400 ↗
• MalfunctionJul 18, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THERE WAS C-ARM UNINTENDED ROTATION. NO INJURIES REPORTED. FIELD ENGINEER WAS DISPATCHED TO SITE AND AFTER INVESTIGATION THE MOTOR AND ROTOR CONTROL BOARDS WERE REPLACED. AFTER THIS THE SYSTEM WAS LEFT WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15045669 ↗
• MalfunctionApr 15, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PATIENT EXAM, WHEN ATTEMPTING TO RAISE THE C-ARM, IT MOVED DOWNWARD INSTEAD AND TRAVELED DOWN UNTIL STOPPING ON ITS OWN. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE FOOT SWITCHES AND C-ARM SWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117448 ↗
• MalfunctionApr 14, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE SYSTEM C-ARM MOVED UNCONMANDED. NO INJURIES REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE DETECTOR ROTATION SWITCH NEEDED TO BE READJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112281 ↗

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