ARIA, RT Chart Application v 8.0 through 8.9 Varian Medical Systems, Palo Alto, CA. Aria Radiation Oncology product is a

FDA device recall Z-2125-2011 · posted 2011-05-02 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC.

Action taken

Varian Medical Systems, Inc. Oncology Systems sent Urgent Medical Device Correction Field Safety Notice letters on March 9, 2011, to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifeid the product, the problem, and the action to be taken by the customer. Customers were instructed to: Manually enter the gantry angel 0.0 when the plan indicates angel 0.0. Manual entry is only allowed to one decimal place, so the range that triggers the issue cannot be created if the keyboard is ued to enter the gantry angel. Users with third party plan sources should verify whether gantry angles with two or more decimal places are supported. If so, customers may be affected by this issue, and should take steps suited to the device. In all cases, the display at the Treatment console is indicative of what direction the gantry will move - users are advised to be especially attentive to these values, particulary when non-zero couch rotation values are used. Users are advised to always run a simulation of the plan, including all plan motions, at the treatment unit prior to first patient treatment. For further clarification customers were insturcted to contact their local Varian Customer Support District Manager. For questions regarding this recall call 650-424-6471.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

612 units

Distribution

Worldwide Distribution - USA including CA, DC, FL, GA, MD, MN, MS, NY, OH, and TN and the countries of Canada, Australia, Austria, Bahrain, Bagladesh, Belarus, Belgium, Brazil, Columbia, Costa Rica, C

Date initiated

2011-03-09

Date posted

2011-05-02

Date terminated

2012-03-13

Location

Palo Alto, CA

Related 510(k) clearances