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U.S. Department of Health and Human Services

Class 2 Device Recall VariSource iX series

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  Class 2 Device Recall VariSource iX series see related information
Date Initiated by Firm May 18, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on September 12, 2016
Recall Number Z-1849-2015
Recall Event ID 71451
510(K)Number K122236  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Code Information JAQ
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
501 Locust Ave
Charlottesville VA 22902-4869
For Additional Information Contact Rachel Forsberg
434-951-8635
Manufacturer Reason
for Recall		 After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).
FDA Determined
Cause 2		 Software Design Change
Action All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.
Quantity in Commerce 55
Distribution Worldwide Distribution.
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 = JAQ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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