ARIA Radiation Therapy Management Software 15.6Recalls & reported problems
Varian Medical Systems, Inc. · Class 2
All models of ARIA Radiation Therapy Management Software (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00856100006110), received between Oct 25, 2024 and Sep 5, 2025 — classified as 3 injuries.
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.
Reports received per month
Recalls naming this device
- Mar 21, 2022Class IICompleted
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Z-0942-2022 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER REPORTED CYBER ATTACK OF THEIR ENTIRE HOSPITAL SYSTEM.
Patient problems: Insufficient Information
MAUDE report 22983915 ↗InjuryFeb 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ARIA DOWN DUE TO 3 DISK FAILURES ON DELL SERVER. CUSTOMER HAS NO SERVICE CONTRACT AND THE DELL SERVER IS OUT OF WARRANTY. A LOCAL SUPPLIER VISIT WAS DONE, HOWEVER THE RECOMMENDATIONS PROVIDED BY THE TECH TO REPAIR THE OS WERE NOT POSSIBLE EVEN AFTER MULTIPLE ATTEMPTS. A DISC REPLACEMENT WILL BE NEEDED AND IS CURRENTLY BEING SOURCED. ALTERNATIVELY, A SERVER REPLACEMENT MAY BE NEEDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21313043 ↗InjuryOct 25, 2024No Apparent Adverse Event; No Apparent Adverse Event
SEE COMPLETED MW-2024-00003, MFR 3003094912-2024-00001.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20533366 ↗
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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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