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U.S. Department of Health and Human Services

Class 2 Device Recall Varian Ximatron CSeries Digital Imaging

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 Class 2 Recall
Varian Ximatron CSeries Digital Imaging
see related information
Date Posted November 08, 2007
Recall Status1 Terminated on February 04, 2008
Recall Number Z-0213-2008
Recall Event ID 38376
Premarket Notification
510(K) Number
Product Classification System, Simulation, Radiation Therapy - Product Code KPQ
Product Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
Code Information Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
Recalling Firm/
Varian Medical Systems Inc
911 Hansen Way
Palo Alto, California 94304
Manufacturer Reason
for Recall
Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.
Quantity in Commerce 14 units
Distribution Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = VARIAN ASSOC., INC.