Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.
FDA Recall Z-2780-2011 · Posted 2011-07-11
Advertisement
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-05-13
Date Terminated2014-08-15
Product Quantity10,097***12-12-12 AMENDED TO: 10664 units***
Reason for Recall
In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions.
Firm Action
Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers.
***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***
The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future.
For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
Root Cause
Software design
Distribution Pattern
Worldwide distribution: Nationwide (USA) and the country of Canada.
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.
Advertisement