Reflexion Medical Radiotherapy System RXM1000 (UDI 00860003983805)Recalls & reported problems
Reflexion Medical, Inc. · The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT (kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It can achieve a nominal dose rate of 850 cGy/min. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860003983805), received between Dec 14, 2021 and Dec 15, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (2 reports).
1 FDA recall record name this device's identifier.
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
- Nov 24, 2021Class IITerminated
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Z-0470-2022 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Application Program Problem: Dose Calculation Error2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unintended Radiation Exposure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
PATIENT (B)(6) RECEIVED 15 OUT OF 25 PLANNED FRACTIONS FOR PROSTATE BED + LYMPH NODE ON THE REFLEXION X1 SYSTEM. DURING THE INITIAL 15 FRACTIONS ON X1, THE PATIENT RECEIVED AN OVERDOSE OF 9.6% TO THE PLANNING TARGET VOLUME (PTV) DUE TO A DEFECT IN THE TREATMENT PLANNING SOFTWARE DOSE CALCULATION. AFTER THE ISSUE WAS IDENTIFIED, HE RECEIVED THE REST OF HIS TREATMENT ON ANOTHER RADIOTHERAPY DEVICE, WITH THE TREATING RADIATION ONCOLOGIST DECIDING TO DROP SOME OF THE REMAINING FRACTIONS TO COMPENSATE. THE ACTUAL FINAL DELIVERED PRESCRIPTION DOSE AMOUNTED TO A 1.25% UNDERDOSE, WHICH STILL MEETS CLINICAL TREATMENT GOALS. THE FINAL, AGGREGATE DELIVERED DOSE TO ALL ORGANS AT RISK STILL FELL WITHIN ACCEPTABLE TOLERANCE DOSE LIMITS. THERE IS NO EXPECTATION THAT THE FINAL DOSE DISTRIBUTION WOULD CAUSE EXCESS RISK OF HARM BEYOND THE BASELINE LEVEL OF RISK OF PROSTATE BED RADIOTHERAPY. ADDITIONALLY, THE INCREASE IN THE RISK OF SECONDARY MALIGNANCY IS MINIMAL IN THIS SCENARIO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13011492 ↗InjuryDec 14, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
PATIENT (B)(6) RECEIVED 22 OUT OF 25 PLANNED FRACTIONS FOR PROSTATE BED + LYMPH NODE ON THE REFLEXION X1 SYSTEM, AND 3 ADDITIONAL FRACTIONS ON ANOTHER SYSTEM. DURING THE COURSE OF HIS TREATMENT, THE PATIENT RECEIVED AN OVERDOSE TO THE PTV OF 7.8%, EXCEEDING CLINICAL TREATMENT GOALS. THERE WERE ASSOCIATED OVERDOSES TO ORGANS AT RISK (OARS). THE ADDITIONAL DOSE TO THESE ORGANS MAY RAISE THE RISK OF SHORT-TERM OR LONG-TERM INJURY BEYOND KNOWN BASELINE RISKS OF PROSTATE BED RADIOTHERAPY.
Patient problems: Unintended Radiation Exposure
MAUDE report 13006612 ↗
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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 · each recall links to the FDA recall notice
- 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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