Aug

2008

Cl Il Varian Medical Systems Oncology Systems

Company: Varian Oncology
Date of Enforcement Report 8/6/2008
Class:ll

PRODUCT
High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator, Recall # Z-1459-2008

REASON
Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient..

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on January 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 systems

DISTRIBUTION
Nationwide

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 Medical Systems Oncology Systems

Amy Sellers

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