Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
FDA Recall Z-0855-2009 · Posted 2009-01-15
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2008-10-02
Date Terminated2010-11-27
Product Quantity64 units
Reason for Recall
When using the multiple static segment option, the device may alter dose delivery.
Firm Action
An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of "Eclipse External Beam Planning Instruction for Use", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
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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