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U.S. Department of Health and Human Services

Class 2 Device Recall Varian High Energy Linear Accelerator

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  Class 2 Device Recall Varian High Energy Linear Accelerator see related information
Date Initiated by Firm May 18, 2011
Date Posted July 08, 2011
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-2764-2011
Recall Event ID 58976
510(K)Number K100890  
Product Classification Accelerator, Linear, medical - Product Code IYE
Product Clinac Linear Accelerator;
Model numbers H14, H27 and H29.


Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Code Information Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396  H271201 H271516 H271975 H272400  H271214 H271521 H271991 H272423  H271250 H271618 H272107 H272445  H271280 H271761 H272125 H272480  H271302 H271843 H272140 H290034  H271311 H271889 H272238 H290192  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.
FDA Determined
Cause 2		 Other
Action Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 18, 2011, via certified mail, return receipt requested. The letter identified the product, problem and recommended actions to be taken. The letter states that customers will be contacted by Varian Service to arrange for replacement of the recalled product. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.
Quantity in Commerce 93
Distribution Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
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
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