ARIA Radiation Therapy Management recall: Software Issue
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Why was ARIA Radiation Therapy Management recalled?
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
- Product
- ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
- Recalling firm
- Varian Medical Systems Imaging Laboratory GmbH
- Quantity
- 14
- 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.
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)