RefleXion Medical Radiotherapy System RXM1000 (UDI 00860003983812)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00860003983812), received between Nov 21, 2023 and Apr 3, 2026 — classified as 24 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Program or Algorithm Execution Problem” (32 reports).

3 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Feb 9, 2026Class IIOpen, Classified

   Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

   Z-1656-2026 · Root cause: Software change control · Recall details · FDA record ↗

2. Jul 22, 2025Class IIOpen, Classified

   Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

   Z-2486-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. Apr 16, 2024Class IIOpen, Classified

   A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

   Z-1933-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE

  Patient problems: Insufficient Information

  MAUDE report 24784116 ↗
• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE

  Patient problems: Insufficient Information

  MAUDE report 24784115 ↗
• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE

  Patient problems: Insufficient Information

  MAUDE report 24784107 ↗
• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE

  Patient problems: Insufficient Information

  MAUDE report 24784106 ↗
• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE

  Patient problems: Insufficient Information

  MAUDE report 24783812 ↗
• InjuryApr 3, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 42.56 GY TO BE DELIVERED IN 16 FRACTIONS, WITH A 2.66

  Patient problems: Insufficient Information

  MAUDE report 24775477 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 24 GY TO BE DELIVERED IN 12 FRACTIONS, WITH A 2 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760525 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 36 GY TO BE DELIVERED IN 20 FRACTIONS, WITH A 1.8 GY P

  Patient problems: Insufficient Information

  MAUDE report 24760516 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 60 GY TO BE DELIVERED IN 30 FRACTIONS, WITH A 2 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760513 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 30 GY TO BE DELIVERED IN 3 FRACTIONS, WITH A 10 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760505 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 14 GY TO BE DELIVERED IN 4 FRACTIONS, WITH A 3.5 GY PL

  Patient problems: Insufficient Information

  MAUDE report 24760501 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 20.5 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 4.1 GY

  Patient problems: Insufficient Information

  MAUDE report 24760493 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 30 GY TO BE DELIVERED IN 15 FRACTIONS, WITH A 2 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760488 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 30 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 6 GY PLAN

  Patient problems: Insufficient Information

  MAUDE report 24760478 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 20 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 4 GY PLAN

  Patient problems: Insufficient Information

  MAUDE report 24760461 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 40 GY TO BE DELIVERED IN 10 FRACTIONS, WITH A 4 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760450 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 25 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 5 GY PLAN

  Patient problems: Insufficient Information

  MAUDE report 24760445 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 66 GY TO BE DELIVERED IN 33 FRACTIONS, WITH A 2 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24760436 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 30 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 6 GY PLAN

  Patient problems: Insufficient Information

  MAUDE report 24760215 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 50 GY TO BE DELIVERED IN 25 FRACTIONS, WITH A 2 GY PLA

  Patient problems: Insufficient Information

  MAUDE report 24759959 ↗
• InjuryApr 1, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED AS MEETING A GREATER THAN 5MM DISPLACEMENT REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 30 GY TO BE DELIVERED IN 5 FRACTIONS, WITH A 6 GY PLAN

  Patient problems: Insufficient Information

  MAUDE report 24758959 ↗
• MalfunctionMar 5, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT MOST AFFECTED TREATMENT SESSIONS WILL HAVE A DISPLACEMENT OF LESS THAN 1MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME; HOWEVER, A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES # 98518, REFLEXION REPORT # 3011716550-02122026-C-00001). SEE H11 FOR ADDITIONAL INVESTIGATION INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24527133 ↗
• MalfunctionMar 5, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT MOST AFFECTED TREATMENT SESSIONS WILL HAVE A DISPLACEMENT OF LESS THAN 1MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME; HOWEVER, A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES# (B)(4), REFLEXION REPORT # (B)(4)). SEE H11 FOR ADDITIONAL INVESTIGATION INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24527130 ↗
• MalfunctionMar 5, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT MOST AFFECTED TREATMENT SESSIONS WILL HAVE A DISPLACEMENT OF LESS THAN 1MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME; HOWEVER, A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES# (B)(4), REFLEXION REPORT # (B)(4)). SEE H11 FOR ADDITIONAL INVESTIGATION INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24527129 ↗
• MalfunctionMar 5, 2026Program or Algorithm Execution Problem

  DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT MOST AFFECTED TREATMENT SESSIONS WILL HAVE A DISPLACEMENT OF LESS THAN 1MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME; HOWEVER, A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES# (B)(4), REFLEXION REPORT # (B)(4)). SEE H11 FOR ADDITIONAL INVESTIGATION INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24527107 ↗