Z-0295-2012

GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems...

Name: Z-0295-2012 GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems...
Creator: Varian Medical Systems, Inc.
Published: 2008-08-05
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-08-05 / Terminated / root cause: manufacturing process

FDA source

Varian Medical Systems, Inc. began a recall of GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan... on 2008-08-05. The reason FDA records is "GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0295-2012
Status: Terminated
Initiated: 2008-08-05
Posted: 2011-11-30
Terminated: 2011-12-07
Recalling firm: Varian Medical Systems, Inc.
Product: GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.
Quantity in commerce: 653 parts
Distribution: Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.
Product codes and lots: Part number GM11002560, Lots E01 to H14

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)