Z-0607-2013Class II

Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and...

Name: Z-0607-2013 Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and...
Creator: Varian Medical Systems, Inc.
Published: 2012-09-28
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-09-28 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and... on 2012-09-28. FDA classified it as Class II and gives the reason as "The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0607-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Posted: 2012-12-20
Terminated: 2013-04-02
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Root cause tag: design
FDA root cause: 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: [email protected].
Quantity in commerce: 15 units
Distribution: Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
Product codes and lots: Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0607-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0607-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code JAQ

K983436Class IIGammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA / cleared 1998-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)