Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.
FDA Recall Z-0455-2011 · Posted 2010-11-24
Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-05-13
Date Terminated2012-02-24
Product Quantity2417 units***12-20-12 AMENDED TO: 49 units***
Reason for Recall
Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record.
Firm Action
On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall.
***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
Root Cause
Software design
Distribution Pattern
Nationwide and Worldwide
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.