Z-2995-2011

Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe...

Name: Z-2995-2011 Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-07-13
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-07-13 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian... on 2011-07-13. The reason FDA records is "Potential of weld failure of the Titanium intrauterine probe at the cervical stopper". 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-2995-2011
Status: Terminated
Initiated: 2011-07-13
Posted: 2011-08-11
Terminated: 2012-06-20
Recalling firm: Varian Medical Systems, Inc.
Product: Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
Root cause tag: design
FDA root cause: Device Design
Action: Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated July 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to return all affected product to Varian Brachy Therapy by using the contact information provided in the letter. Replacement product will be provided free of charge to the customers. Customers should contact their local Varian Customer Support District or Regional Manager for questions regarding this notice.
Quantity in commerce: 437 - all sizes
Distribution: Worldwide Distribution.
Product codes and lots: Product number applicator Set: GM11006200;40 mm, 30 degree angle probe product number: GM11006140.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)