Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
FDA Recall Z-0861-2009 · Posted 2009-02-20
Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-11-21
Date Terminated2011-03-10
Product Quantity516 units
Reason for Recall
Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.
Firm Action
An Urgent Device Correction product notification letter/field safetly letter dated November 21, 2008, was distributed to all affected users, with a description of the problem and user corrective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizations, informing them of the issue.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: USA, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom.
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.