Jul

2002

Inc Class II Varian Medical Systems

Company: Varian Medical Systems, Inc
Date of Enforcement Report: 7/3/2002
Class: II

PRODUCT
Varian Medical System’s Eclipse VERSION 6.5 software, a proprietary application for Varian Vision ™ imaging systems. Recall # Z-1109-2.

REASON
Radiation treatment planning software malfunction could result in incorrect treatment regimen.

CODE
Eclipse software, version 6.5, Serial Numbers:
0016
0018
0022
0034
0044
0045
0051
0052
0053
0054
0055
0056
0057
0058
0059
0060
0061
0062
0068
0069
0107
0108
0119
0133
0134
0135
0138
0139
0148
0149
0150
0181
0187
0188
0189
0210
0212
0213
0243
0248
0249.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Inc., Palo Alto, CA, by letter, telephone and fax on February 14, 2002.
Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
37 units.

DISTRIBUTION
AL, GA, IN, KY, MS, MI, and NY and Japan.

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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Inc Class II Varian Medical Systems

Amy Sellers

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