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Terminated

Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA

FDA Recall Z-0531-2013 · Posted 2012-12-17

Recall StatusTerminated
Product CodeIYE
Date Initiated2012-11-05
Date Terminated2014-03-03
Product Quantity264 units

Reason for Recall

Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.

Firm Action

Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. US and Canada 1-888-827-4265. For questions regarding this recall call 650-424-5731.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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