21
Oct
2009

Cl Il Eclipse Proton Convolution Superposition DC

0

Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009

REASON
Software Issue/Mistreatment Potential — Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered..

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on July 17, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 units

DISTRIBUTION
TX

About the author

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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