ARIA Radiation Therapy Management (RTM) 16.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856100006165), received between Feb 16, 2022 and Jan 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173838, K221408); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ARIA SERVER AND BACKUP TAPE DRIVE SUFFERED WATER DAMAGE AND ARE DEFECTIVE. IT WAS SEEN CONDENSATION INSIDE THE SMALL LCD SCREEN OF THE SERVER'S FRONT PANEL, SERVER WAS DISCONNECTED. IT WAS NOTICED, THAT IN CD DRIVE, SSDS AND TAPE BACKUPS WAS WATER INSIDE AS WELL. FROM THE PHYSICAL INSPECTION OF THE SERVER, IT WAS CONCLUDED THAT IT HAD SHORT CIRCUITED DUE TO MOISTURE FROM THE FAULTY AC UNIT AND IS UNRECOVERABLE, AND THE SITE WOULD THEREFORE NEED A NEW REPLACEMENT SERVER. SYSTEM WENT DOWN ON 4TH DEC 2023 DUE TO WATER ON THE SERVER, THIS CAUSED TREATMENT DELAY FOR AT LEAST 2 WEEKS. THE CUSTOMER REFUSED TO GIVE US ANY PATIENT DATA.

  Patient problems: Insufficient Information

  MAUDE report 18426624 ↗
• MalfunctionFeb 16, 2022Computer Software Problem; Improper or Incorrect Procedure or Method; Compatibility Problem; Computer Software Problem; Improper or Incorrect Procedure or Method; Compatibility Problem

  PER INFORMATION PROVIDED BY THE CUSTOMER, A PATIENT WAS BEING TREATED FOR LUNG CANCER TO A DOSE OF 60 GY IN 30 FRACTIONS USING PROTONS ON A MEVION HYPERSCAN 250I, TREATMENT PLANNING ON RAYSTATION AND WITH ARIA 16.1 FOR RECORDING AND VERIFICATION. ON FRACTION 4, THE TABLE POSITION OF THE SETUP FIELD WAS ERRONEOUSLY CHANGED BY THE USER AFTER TREATMENT APPROVAL WITHOUT ALSO UPDATING THE TREATMENT POSITION. A TOTAL OF 3 FRACTIONS WERE TREATED CORRECTLY BUT 20 WERE TREATED INCORRECTLY. THIS RESULTED IN A TREATMENT SIGNIFICANTLY INFERIOR TO THE TARGET WITH 20 FRACTIONS BEING DELIVERED TO NORMAL LUNG, MEDIASTINUM, HEART, ETC. WHEN THE MISADMINISTRATION WAS NOTICED, THE PATIENT'S PLAN WAS CONVERTED TO A PHOTON PLAN AND WAS DELIVERED USING ADAPTIVE RADIATION FOR 27 FRACTIONS SINCE THE 20 MIS-ADMINISTERED FRACTIONS DID NOT TOUCH THE TUMOR.

  Patient problems: Insufficient Information

  MAUDE report 13543300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173838, K221408. One submission often covers many models, so check the product and lot details in each record.

• Z-0942-2022 · Mar 21, 2022 · Completed
  ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1