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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Segmented Cervix Applicator 		see related information
Date Posted December 20, 2012
Recall Number Z-0607-2013
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/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville, Virginia 22903-4584
For Additional Information Contact Mika Miettinen
434-977-8495
Reason for
Recall		 The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
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.
 
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