Recall Z-2153-2012— Varian Medical Systems, Inc. Oncology Systems

Name: FDA recall Z-2153-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-07-02, terminated 2013-07-01. It names one FDA 510(k) clearance: K093527. 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.. Reason: 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..

Recalling firm: Varian Medical Systems, Inc. Oncology Systems
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Terminated: 2013-07-01
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K093527 — ARIA RADIATION ONCOLOGY WITH MIRSVarian Medical Systems, Inc.·cleared 2009-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.