Mammomat Fusion 10762444Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869009070), received between Sep 14, 2023 and Feb 23, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Installation-Related Problem” (1 report).

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

• MalfunctionFeb 23, 2026Installation-Related Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN INSTALLATION ISSUE INVOLVING THE MAMMOMAT FUSION SYSTEM. ACCORDING TO THE COMPLAINT REPORT, THIS SYSTEM WAS NOT CORRECTLY INSTALLED IN A MOBILE UNIT. ALTHOUGH NO INJURY WAS COMMUNICATED, AN INCORRECT INSTALLATION OF THIS SYSTEM IN A MOBILE UNIT COULD RESULT IN A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413145 ↗
• MalfunctionSep 14, 2023Unintended Electrical Shock; Unintended Electrical Shock

  DURING TRAINING AT THE SIEMENS HEALTHINEERS TRAINING CENTER, A SERVICE ENGINEER FELT AN ELECTRICAL SHOCK WHILE REPLACING THE MAIN FILAMENT INVERTER (MFI) BOARD. THE SERVICE ENGINEER STATED HE EXPERIENCED SOME TEMPORARY NUMBNESS IN THE AFFECTED ARM. ASIDE FROM THE TEMPORARY NUMBNESS, NO INJURIES WERE FOUND DURING A MEDICAL EXAMINATION HE RECEIVED AFTER THE INCIDENT. THE ENGINEER CONFIRMED ON (B)(6) 2023 THAT HE HAD NO LASTING EFFECTS AND THAT THERE WERE NO BURN MARKS.

  Patient problems: Electric Shock

  MAUDE report 17746167 ↗