Cl Il Varian Medical Systems On-Board Imager

Company: Varian Medical Systems Oncology Systems
Date of Enforcement Report 8/20/2008

Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks, Recall # Z-1442-2008

If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.

Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters starting January 3, 2008. Firm initiated recall is ongoing.

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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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