MRIdian LINAC 20000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10868029000305), received between Dec 1, 2021 and Feb 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Radiation Overexposure; Radiation Overexposure

  A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN ISSUE WITH THE A3I DELIVERY CALENDAR. THE SITE REVISED A PATIENT'S PLAN AFTER TWO (2) FRACTIONS. THE REVISED PLAN WAS PLACED INTO A NEW DELIVERY CALENDAR. THE REMAINING FRACTIONS OF THE ORIGINAL DELIVERY CALENDAR WERE LOCKED ON THE TREATMENT PLANNING SYSTEM (TPS) AS PER THE MRIDIAN LINAC OPERATOR'S MANUAL (L-0240), BUT WHEN THE THERAPIST WENT TO TREAT THE PATIENT THEY NOTICED THAT THE LOCKED FRACTIONS WITHIN THE ORIGINAL PLAN WERE STILL AVAILABLE FOR DELIVERY. THE SITE INDICATED THAT THIS IS DIFFERENT BEHAVIOR AS COMPARED TO THE WAY THE DELIVERY CALENDAR USED TO PERFORM IN THE V2 SOFTWARE VERSION. WITH THE A3I SOFTWARE, THE SITE WAS UNCLEAR PER THE MRIDIAN LINAC OPERATOR'S MANUAL (L-0240) HOW TO DEACTIVATE UNUSED FRACTIONS IN THE PARTIALLY DELIVERED DELIVERY CALENDAR AND ALSO HOW TO DEACTIVATE SOME FRACTIONS ON THE NEW DELIVERY CALENDAR.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16311656 ↗
• MalfunctionJan 7, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Jam; Inadequate Lubrication; Mechanical Problem; Detachment of Device or Device Component; Mechanical Jam; Inadequate Lubrication

  VIEWRAY'S DISTRIBUTOR REPORTED AN OCCURRENCE WHERE THE GANTRY CAME OFF THE VAULT PLATE AND PRODUCED AN ERROR MESSAGE. THE SYSTEM DISPLAYED ERROR MESSAGE RT08011 WITH A DIALOG MESSAGE STATING "GANTRY MOTOR OPERATING CURRENT LIMITS HAVE BEEN EXCEEDED. CALL SERVICE." THIS ERROR CODE IS A HARDWARE ERROR. THE ERROR CODE IS CAUSED BY HARDWARE ISSUE. THE SYSTEM SHOWS THE ERROR MESSAGE AND ABORTS TREATMENT IF IN SESSION. THE USER SHOULD CALL VIEWRAY SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191204 ↗
• MalfunctionDec 1, 2021Program or Algorithm Execution Problem; Program or Algorithm Execution Problem

  A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN OCCURRENCE IN THE PLANNING/FUSION WORKFLOW WHERE: 1. MANUAL TRANSLATION SHIFT CANNOT BE APPLIED CORRECTLY TO SECONDARY DOSE VOLUME WHEN SECONDARY DOSE AND SECONDARY CT COMES FROM OTHER VENDOR A. MANUALLY ALIGN SECONDARY CT AND PRIMARY MRI. B. APPLY THE SAME TRANSLATION VALUE TO THE SECONDARY DOSE WHICH IS ASSOCIATED TO THE CT. C. OBSERVED THAT SECONDARY DOSE VOLUME IS NOT ALIGNED WITH PRIMARY MRI AND REGISTERED CT. 2. MANUAL TRANSLATION SHIFT CANNOT BE APPLIED CORRECTLY TO SECONDARY DOSE VOLUME WHEN SECONDARY DOSE AND SECONDARY MRI GENERATED FROM MRIDIAN SYSTEM BUT AT A DIFFERENT FOV COMPARED TO PRIMARY MRI. A. MANUALLY ALIGN SECONDARY MRIDIAN MRI AND PRIMARY MRIDIAN MRI. B. APPLY THE SAME TRANSLATION VALUE TO THE SECONDARY DOSE WHICH IS ASSOCIATED TO THE SECONDARY MRIDIAN MRI. C. OBSERVED THAT SECONDARY DOSE VOLUME IS NOT ALIGNED WITH PRIMARY MRI AND REGISTERED MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913779 ↗