EXCELSIUS3D 6161.1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193982184506), received between Jul 25, 2024 and Feb 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A SURGERY USING THE EXCELSIUS 3D IT GAVE "EXCELSIUS 3D ERROR CODE 17 X RAY GENERATOR ERROR." THEY WENT TO DO A SPIN FOR SI FUSION AND THIS CODE POPPED UP. THEY ALSO GOT THE FOLLOWING MESSAGES; "SYSTEM IS UNABLE TO ACQUIRE IMAGE DUE TO THE FOLLOWING REASONS: REASON #1: X-RAY GENERATOR ERROR. IF PROBLEM PERSISTS FOR MORE THAN 1 MIN, RESET X-RAY ON THE SETTINGS PAGE. IF THE PROBLEM CONTINUES, CONTACT SERVICE. REASON # 2: THE X-RAY GENERATOR IS NOT READY. SYSTEM IS ATTEMPTING TO REMEDY. IF UNFIXED, RESET X-RAY IN SETTINGS. CONTACT SERVICE IF THE PROBLEM PERSISTS. REASON #3: THE X-RAY GENERATOR HAS EXPERIENCED THE FOLLOWING ERRORS): ERROR 17: FILLAMENT SYSTEM.. SYSTEM IS ATTEMPTING TO CLEAR. IF UNFIXED, RESET X-RAY IN SETTINGS. CONTACT SERVICE IF THE PROBLEM PERSISTS." THEY HAD TO CANCEL THE SURGERY DUE TO THESE MESSAGES, THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251345 ↗
• MalfunctionJul 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A POTENTIAL BATTERY ISSUE WITH THE EXCELSIUS 3D IMAGING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829162 ↗
• MalfunctionJul 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A POTENTIAL BATTERY ISSUE WITH THE EXCELSIUS 3D IMAGING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829141 ↗
• MalfunctionJul 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS A POTENTIAL BATTERY ISSUE WITH THE EXCELSIUS 3D IMAGING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829119 ↗