Cl ll FastPlan Treatment Planning System

Company:Varian Medical Systems, Inc.
Date of Enforcement Report 5/9/12
Class ll:

PRODUCT
FastPlan Treatment Planning System, Model HZ3, Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software. Recall # Z-1217-201

REASON
An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to “Discard” that slice, an incorrect calculation of the isocenter location may result.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on January 30, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
201 units

DISTRIBUTION
Nationwide and Internationally

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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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