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U.S. Department of Health and Human Services

Class 2 Device Recall Brachytherapy System, Remote Afterloader

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  Class 2 Device Recall Brachytherapy System, Remote Afterloader see related information
Date Initiated by Firm March 01, 2010
Date Posted December 01, 2011
Recall Status1 Terminated 3 on May 30, 2013
Recall Number Z-0325-2012
Recall Event ID 59885
510(K)Number K071467  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.

The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.
Code Information Serial numbers: 212, 215, 222, 224, 239, 246, 271, 274, 281, 293, 308, 322, 333, 343, 346, 388, 394, 401, 403, 406, 411, 431, 436, 437, 438, 441, 444, 446, 450, 456, 462, 500, 501, 505, 509, 510, 511, 512, 513, 514, 515, 516, 518, 519, 521, 522, 527, 530, 532, 535, 536, 538, 539, 540, 541, 542, 544, 545, 546, 548, 551. Part Number: AL20020000 (VariSource iX Afterloader
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Mark Kattmann
434-977-8495
Manufacturer Reason
for Recall		 VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
FDA Determined
Cause 2		 Software design
Action Varian Medical Systems sent a "MEDICAL DEVICE RECALL" letter dated April 1, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to conduct a simple test to establish if their machine is affected by the problem. Device users were requested to complete an attached receipt verification form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.
Quantity in Commerce 72 worldwide/50 in U.S.
Distribution Worldwide Distribution-USA (nationwide)
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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