Z-0170-2016Class II

ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT

Name: Z-0170-2016 ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT
Creator: Varian Medical Systems, Inc.
Published: 2015-09-28
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2015-09-28 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. began a recall of ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a... on 2015-09-28. FDA classified it as Class II and gives the reason as "An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0170-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Posted: 2015-10-30
Terminated: 2017-05-12
Recalling firm: Varian Medical Systems, Inc.
Product: ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Varian sent an Urgent Medical Device Corrections letter dated September 29, 2015 via trackable method to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service. A copy of the notification is to be kept with the most current product labeling and all appropriate personnel in the radiation oncology department should be aware of this issue. For questions contact your local Varian Medical Systems Customer Support District or Regional Manager
Quantity in commerce: 1971 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.
Product codes and lots: Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-27

Product code MUJ

K093527Class IIAria Radiation Oncology with MirsVarian Medical Systems, Inc. / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)