Feb

2009

Cl Il Varian Eclipse treatment planning system

Company:Varian Medical Systems
Date of Enforcement Report 2/25/2009
Class:ll

PRODUCT
Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Recall # Z-0861-2009

REASON
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.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems oncology Systems, Palo Alto, CA, by letter dated November 21, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
516 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il Varian Eclipse treatment planning system

Amy Sellers

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