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U.S. Department of Health and Human Services

Class 2 Device Recall Segmented Cervix Applicator

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  Class 2 Device Recall Segmented Cervix Applicator see related information
Date Initiated by Firm September 28, 2012
Date Posted December 20, 2012
Recall Status1 Terminated 3 on April 02, 2013
Recall Number Z-0607-2013
Recall Event ID 63667
510(K)Number K983436  
Product Classification System, Applicator, Radionuclide, Remote-controlled - Product Code JAQ
Product Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves

The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
Code Information Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547.
Recalling Firm/
Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Mika Miettinen
Manufacturer Reason
for Recall
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
FDA Determined
Cause 2
Device Design
Action The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE" letter dated September 28, 2012 to all affected consignees/Customers. The letter identified the affected product, description of problem and recommended user actions to be taken. The consignees/customers were instructed to immediately remove all affected guiding tubes from clinical use, and sequester the components for pending return to Varian Brachy Therapy. Consignees/Customers were requested to complete the attached proof of notification form and return it to Varian Medical Systems. For questions contact-AT&T international direct dialing network (http://www.business.att.com/bt/dial_guide.isp. Then after hearing the AT&T signature noise, and. "Please enter the number you are calling", dial 800-360-7909; UK:+44 1293-601-327 or US:+1-434-979-1540. To submit a support request or general inquiry, compose an email with a blank subject line to: brachyhelp@varian.com.
Quantity in Commerce 15 units
Distribution Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
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 = GAMMAMED USA