ARIA Radiation Therapy Management Software recallZ-0942-2022 · Varian Medical Systems Imaging Laboratory GmbH · initiated Mar 21, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Varian Medical Systems Imaging Laboratory GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
FDA root cause category: Software Design Change
What the company is doing
On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions: Please retain a copy of this document along with your most current product labeling. Advise the appropriate personnel working in your radiotherapy department of the content of this letter. This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. Please complete the attached Return Response form provided. Kindly return the completed form to [email protected].
Recall details
- Recall number
- Z-0942-2022
- Status
- Completed
- Initiated by the company
- Mar 21, 2022
- Recalling firm
- Varian Medical Systems Imaging Laboratory GmbH
- Quantity
- 14
- Product code
- IYE
- FDA submissions
- K133572, K173838
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.
Product description
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Code information (models, lots, serial numbers)
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARIA Radiation Therapy Management Software 15.6Varian Medical Systems, Inc. · Accelerator, linear, medical1 recall3 reports
- ARIA Radiation Therapy Management Software 15.1Varian Medical Systems, Inc. · Accelerator, linear, medical1 recall1 report
- ARIA Radiation Therapy Management Software 13.6Varian Medical Systems, Inc. · Accelerator, linear, medical1 recall0 reports
- ARIA Radiation Therapy Management Software 15.5Varian Medical Systems, Inc. · Accelerator, linear, medical1 recall0 reports
- ARIA Radiation Therapy Management Software 16.0Varian Medical Systems, Inc. · Accelerator, linear, medical1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K133572, K173838 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARIA Radiation Therapy Management (RTM) 16.1Varian Medical Systems, Inc. · Accelerator, linear, medical2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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