Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error
Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect radiation dosing (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Varian Medical Systems, Inc. Oncology Systems is recalling 205 units of ARIA Radiation Oncology, Version 11. This product is a treatment plan and image management application used in radiation oncology. The recall covers units distributed worldwide, including the United States, Australia, Denmark, and the United Kingdom.
The recall was initiated because an anomaly was identified where Monitor Units of one fraction may be incorrect when partial treatment is being continued. This software error could affect the accuracy of radiation treatment plans.
Healthcare facilities and users of the ARIA Radiation Oncology software should contact Varian Medical Systems for instructions on how to address the anomaly and ensure treatment plans are accurate.
The recalled product
- Product
- ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 205
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Varian Medical Systems, Inc. Oncology Systems
See all →- HighVarian High Energy Clinacs Radiation Treatment System Recall for Beam Symmetry
FDA (Devices) · 2013-05-22
- ModerateVarian RPM Respiratory Gating System Recall for Waveform Anomaly
FDA (Devices) · 2013-05-01
- HighVarian Eclipse Treatment Planning System Recalled for Dose Calculation Error
FDA (Devices) · 2013-02-27
- HighVarian ARIA Radiation Oncology System Recall for DICOM Export Anomaly
FDA (Devices) · 2012-12-26
- SevereVarian Eclipse Treatment Planning System Recalled for Dose Calculation Error
FDA (Devices) · 2012-10-03
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateVarian ARIA Radiation Oncology Software Recall for Printing Anomaly
FDA (Devices) · 2015-11-04
- HighVarian Eclipse Treatment Planning System Software Deficiency Recall
FDA (Devices) · 2014-01-01
- HighVarian ARIA Oncology Software Recall Due to Incorrect MLC Data Import
FDA (Devices) · 2012-08-15
- HighVarian ARIA Radiation Oncology System Recall for DICOM Export Anomaly
FDA (Devices) · 2012-12-26
- HighARIA Radiation Therapy Management Software May Cause Treatment Location Error
FDA (Devices) · 2022-04-20
- HighElekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error
FDA (Devices) · 2016-01-13