22
Feb
2008

Varian Medical Systems Inc Radiation System Cl II

0

Company: Varian Medical Systems Inc,
Date of Enforcement Report 2/20/2008
Class:ll

PRODUCT
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models, Recall # Z-0720-2008

REASON
Incorrect Software Validation. The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc, Palo Alto, CA, by letter on October 2, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
440 units

DISTRIBUTION
Nationwide and Internationally

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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