MAMMOMAT B.brilliant 11372950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869987187), received between Feb 23, 2026 and Feb 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Collision” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Unintended Collision

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE INVOLVING THE MAMMOMAT B.BRILLIANT SYSTEM. ACCORDING TO THE PROVIDED INFORMATION, THE SWIVEL ARM OF THE SYSTEM COLLIDED WITH A BIOPSY CHAIR WHICH WAS POSITIONED WITHIN IN THE COLLISION RANGE OF THE TUBE ARM. ON (B)(6) INFORMATION WAS RECEIVED THAT A PATIENT WAS SITTING IN THE CHAIR AND WAS COMPRESSED DURING THE COLLISION. NO PATIENT INJURY WAS COMMUNICATED. IN A WORST-CASE SCENARIO, A CRITICAL INJURY COULD RESULT IF THE ISSUE WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413154 ↗