26
Mar
2003

Inc Class II Varian Medical Systems

0

Company: Varian Medical Systems, Inc
Date of Enforcement Report: 3/26/03
Class: II

PRODUCT
VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03.

REASON
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.

CODE
Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letters on January 16, 2003 and February 4, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 units.

DISTRIBUTION
CA, MA, NC, SC, PA, LA, Canada, Austria, Germany and Finland.

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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