Varian Medical Systems, Inc. Oncology Systems: Medical Device Recall in 2012 - (Recall #: Z-2153-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 2, 2012

Date Posted: August 15, 2012

Recall Number: Z-2153-2012

Event ID: 62562

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.

Status: Terminated

Product Quantity: 2 Units.

Code Information:

Serial Numbers/CODES: HIT0535, HIT2953

Distribution Pattern:

Nationwide Distribution including the states of New York and Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated