Nov

2009

6.1 and 6.0 when used with LINK, Cl Il VARiS 6.2

Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 11/25/2009
Class:ll

PRODUCT
VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010

REASON
Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 15, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
100 units

DISTRIBUTION
Nationwide and Internationally

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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6.1 and 6.0 when used with LINK, Cl Il VARiS 6.2

Amy Sellers

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