MRIdian Linac System 20000-01Recalls & reported problems
Viewray Incorporated · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00868029000346), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Recalibrate” (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
Device problems
- Failure to Recalibrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2023Failure to Recalibrate; Failure to Recalibrate
ON 20APRIL2023 A USER OF VIEWRAY'S MRIDIAN LINAC SYSTEM REPORTED AN ISSUE WITH THEIR SYSTEM'S GANTRY ANGLES MEASURING 1.7 DEGREES OUT OF SPECIFICATION. ON (B)(6) 2023 THE GANTRY OFFSETS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. DUE TO A MISTAKE BY A SITE OPERATOR ON (B)(6) 2023, AN EMERGENCY STOP WAS MISTAKENLY PRESSED CAUSING THE SYSTEM TO POWER DOWN. UPON POWERING THE SYSTEM BACK ON, THE VIEWRAY ONSITE ENGINEER IDENTIFIED THAT THE INCLINOMETER HAD FAILED RESULTING IN AN INCLINOMETER REPLACEMENT. ON (B)(6) 2023, THE SITE IRRADIATED ONE PATIENT AND AFTER TREATMENT, THE SITE DISCOVERED DURING QUALITY ASSURANCE CHECKS THAT THE GANTRY ANGLE WAS 1.7 DEGREES OFF. THE SITE REPORTED THERE WERE NO CONSEQUENCES FOR THE PATIENT SINCE THE TARGET VOLUME WAS CENTRAL AND SYMMETRICAL, AND THEREFORE NO RELEVANT DOSE DEVIATIONS OCCURRED. THIS WAS CONFIRMED BY RECALCULATION IN THE RADIATION PLANNING SYSTEM WITH DIFFERENT GANTRY ANGLES. ON (B)(6) 2023 VIEWRAY FIELD SERVICE ENGINEER CALIBRATED THE INCLINOMETER AND GANTRY OFFSETS BACK TO 0.0 DEGREES. THE CUSTOMER PERFORMED A STARSHOT ANALYSIS TO VERIFY AND CONFIRM THE INCLINOMETER AND GANTRY ANGLES WERE WITHIN SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17101286 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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