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Terminated

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

FDA Recall Z-0552-2014 · Posted 2013-12-20

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-11-18
Date Terminated2015-03-13
Product Quantity6701

Reason for Recall

An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

Firm Action

Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131807HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems, Inc. · 2013-10-11K093527ARIA 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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