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Terminated

Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 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 departments clinical and business information.

FDA Recall Z-0713-2012 · Posted 2012-01-11

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-12-16
Date Terminated2014-08-06
Product Quantity2235 units***12-12-12 AMENDED TO: 2984 units***

Reason for Recall

Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation.

Firm Action

Varian sent an "Urgent Medical Device Correction - Urgent Field Safety Notice" letter dated December 16, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, problem and recommended user actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems. For questions contact your Varian Customer Support District or Reginal Manager.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093527ARIA RADIATION ONCOLOGY WITH MIRSVarian Medical Systems, Inc. · 2009-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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