Z-2081-2008

VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring...

Name: Z-2081-2008 VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring...
Creator: Varian Medical Systems, Inc.
Published: 2008-03-12
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-03-12 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000... on 2008-03-12. The reason FDA records is "Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment". 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-2081-2008
Status: Terminated
Initiated: 2008-03-12
Posted: 2008-09-16
Terminated: 2012-11-28
Recalling firm: Varian Medical Systems, Inc.
Product: VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified medical device users by letter on 03/12/08. The notification provided updated instructions for use for the CT/MR Ring and Tandem Combination Applicator Set. Users were advised to characterize all ring applicators to develop an offset correction for each dwell position in order to construct a plan to deliver the dwell positions accurately and reliably. The characterization can be done by creating a set of autoradiographs with intended dwell positions and define treatment plan shifts in order to deliver dwell positions in intended locations. Users were advised that a subsequent set of verification autoradiographs should be made using the derived plan shifts to verify the corrected source positioning. The notification also advised that an individual ring's behavior can change over its duration of use and that periodic commissioning is dictated to ensure reproducibility and compensate for changes in the device over time. Users were instructed to inform all employees and extend the notice to any consignees. Users were requested complete and return the enclosed response form. If you have questions about this recall, send an email to brachyhelp@varian,com.
Quantity in commerce: 120 units
Distribution: The medical devices were distributed to radiation oncology facilities nationwide.
Product codes and lots: catalog # AL13017000, all lots

Product code JAQ

K030110Class IICT Hdr Tandem/ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. / cleared 2003-04-03

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)