Z-1200-2012

Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used...

Name: Z-1200-2012 Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used...
Creator: Varian Medical Systems, Inc.
Published: 2012-01-05
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-01-05 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product... on 2012-01-05. The reason FDA records is "Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients". 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-1200-2012
Status: Terminated
Initiated: 2012-01-05
Posted: 2012-03-12
Terminated: 2012-11-21
Recalling firm: Varian Medical Systems, Inc.
Product: Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
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 January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.
Quantity in commerce: 122 total units
Distribution: Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
Product codes and lots: All lots of the components are recalled. Components are used as adapters for the Varian Afterloaders with the following serial numbers: H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583

Product code JAQ

K071467Class IIVarisource IX Hdr AfterloaderVarian Medical Systems, Inc. / cleared 2007-07-16

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)