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Class 2 Device Recall Varian |
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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
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Product Classification |
Accelerator, Linear, Medical - Product Code IYE
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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
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For Additional Information Contact |
Lynne McBride 714-993-5321
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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