Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeve
FDA device recall Z-0607-2013 · posted 2012-12-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 15 units
- Distribution
- Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
- Date initiated
- 2012-09-28
- Date posted
- 2012-12-20
- Date terminated
- 2013-04-02
- Location
- Charlottesville, VA
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| GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436) | Gammamed USA | 1998-10-29 |