Z-2153-2012Class II

Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA...

Name: Z-2153-2012 Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2012-07-02
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-07-02 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is... on 2012-07-02. FDA classified it as Class II and gives the reason as "A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported". 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-2153-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-08-08
Terminated: 2013-07-01
Recalling firm: Varian Medical Systems, Inc.
Product: Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.
Root cause tag: software
FDA root cause: Software design
Action: Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your system. For further questions please call 1.888.827.4265.
Quantity in commerce: 2 Units.
Distribution: Nationwide Distribution including the states of New York and Ohio.
Product codes and lots: Serial Numbers/CODES: HIT0535, HIT2953

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2153-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2153-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-07

Product code IYE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)