Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System
FDA Recall Z-0911-2011 · Posted 2011-01-18
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Recalling FirmVarian Medical Systems, Palo Alto, CA
Recall StatusTerminated
Product CodeMUJ
Date Initiated0010-08-17
Date Terminated2011-07-21
Product Quantity7019
Reason for Recall
Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose.
Firm Action
Varian Medical Systems Urgent Medical Device Correction letters were sent to all affected users on August 6, 2010. Letters were also sent to Varian Sales, Marketing and Service organizations to inform them of the recall.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution.
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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