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Terminated

Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.

FDA Recall Z-2231-2009 · Posted 2009-09-22

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-07-17
Date Terminated2010-11-27
Product Quantity1

Reason for Recall

Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.

Firm Action

Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.

Root Cause

Software design

Distribution Pattern

Product was distributed to one user in Texas

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071873MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc. · 2007-08-09

Official Source

View FDA Recall →

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

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