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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 Device Recall Varian Ximatron CSeries Digital Imaging see related information
Date Initiated by Firm June 25, 2007
Date Posted November 08, 2007
Recall Status1 Terminated 3 on February 04, 2008
Recall Number Z-0213-2008
Recall Event ID 38376
510(K)Number K851653  
Product Classification Oncology Information System - 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/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact
650-424-5731
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = VARIAN ASSOC., INC.
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