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U.S. Department of Health and Human Services

Class 2 Device Recall Varian

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  Class 2 Device Recall Varian see related information
Date Initiated by Firm January 31, 2003
Date Posted March 12, 2003
Recall Status1 Terminated 3 on September 17, 2003
Recall Number Z-0633-03
Recall Event ID 25575
510(K)Number K001643  
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
Code Information Affected Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94303
For Additional Information Contact Lynne McBride
714-993-5321
Manufacturer Reason
for Recall		 The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
FDA Determined
Cause 2		 Software design
Action On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.
Quantity in Commerce 12 units
Distribution Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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