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.
FDA Recall Z-0607-2013 · Posted 2012-12-20
Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated2012-09-28
Date Terminated2013-04-02
Product Quantity15 units
Reason for Recall
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Firm 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: [email protected].
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.