Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly
Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.
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 with a functional defect that could impact treatment accuracy, but the source text does not report any injuries, illnesses, or fatalities, 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 264 units of the ARIA Oncology Information System Radiation Oncology, Import Export Application. The affected software versions are ARIA version 11.0 below 11.0.55, specifically Build 11.0.28 and 11.0.34. The product is manufactured and distributed by Varian Medical Systems Inc. in Palo Alto, CA, and was distributed worldwide.
The recall was initiated because Varian identified an anomaly in the DICOM import/export functionality. Specifically, a 360-degree arc field may convert to a static field during the DICOM export or import process. This software defect could impact the accuracy of radiation treatment planning data.
Healthcare facilities and users of the ARIA system should contact Varian Medical Systems for instructions on how to resolve the issue. The source text does not specify a particular action for end-users other than the recall notification.
The recalled product
- Product
- Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured…
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Affected units
- 264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CODES: HITOO28
- HIT0963
- HITl780
- HIT242S
- HIT4118RI
- HIT0632M
- HITIS87R4
- HIT2208RS
- HID088R6
- HITOO32
- HIT0983M
- HITl800
- HIT2434
- HIT4263
- HlT0632Rl
- HlTlS89M
- HIT2212
- HIT3097
- HITOO49M
- HIT0983RI
Distribution
Distribution scope not specified by the agency.
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