ARIA Radiation Therapy Management SoftwareRecalls & reported problems across all models
Varian Medical Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 5 models of ARIA Radiation Therapy Management Software by Varian Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2024 and Sep 5, 2025 — classified as 4 injuries.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ARIA Radiation Therapy Management Software recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 21, 2022Completed
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 · names 5 of these models · Recall details · FDA record ↗
Most reported ARIA Radiation Therapy Management Software problems
Device problems
- No Apparent Adverse Event3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
ARIA Radiation Therapy Management Software models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARIA Radiation Therapy Management Software 15.6Accelerator, linear, medical1 recall3 reports
- ARIA Radiation Therapy Management Software 15.1Accelerator, linear, medical1 recall1 report
- ARIA Radiation Therapy Management Software 13.6Accelerator, linear, medical1 recall0 reports
- ARIA Radiation Therapy Management Software 15.5Accelerator, linear, medical1 recall0 reports
- ARIA Radiation Therapy Management Software 16.0Accelerator, linear, medical1 recall0 reports
Recent ARIA Radiation Therapy Management Software adverse event reports
The 4 most recent reports across all models, 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 ↗InjuryJan 16, 2025No Apparent Adverse Event; No Apparent Adverse Event
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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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