Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.
FDA Recall Z-1412-2010 · Posted 2010-04-20
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-12-09
Date Terminated2012-02-24
Product Quantity3177 unit
Reason for Recall
Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.
Firm Action
Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.
Root Cause
Software design
Distribution Pattern
Nationwide distribution and Mexico.
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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