Z-0325-2012

VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX...

Name: Z-0325-2012 VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX...
Creator: Varian Medical Systems, Inc.
Published: 2010-03-01
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-03-01 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. began a recall of VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dose Rate Afterloader system is a computer... on 2010-03-01. The reason FDA records is "VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0325-2012
Status: Terminated
Initiated: 2010-03-01
Posted: 2011-12-01
Terminated: 2013-05-30
Recalling firm: Varian Medical Systems, Inc.
Product: VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
Root cause tag: software
FDA root cause: Software design
Action: Varian Medical Systems sent a "MEDICAL DEVICE RECALL" letter dated April 1, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to conduct a simple test to establish if their machine is affected by the problem. Device users were requested to complete an attached receipt verification form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.
Quantity in commerce: 72 worldwide/50 in U.S.
Distribution: Worldwide Distribution-USA (nationwide)
Product codes and lots: Serial numbers: 212, 215, 222, 224, 239, 246, 271, 274, 281, 293, 308, 322, 333, 343, 346, 388, 394, 401, 403, 406, 411, 431, 436, 437, 438, 441, 444, 446, 450, 456, 462, 500, 501, 505, 509, 510, 511, 512, 513, 514, 515, 516, 518, 519, 521, 522, 527, 530, 532, 535, 536, 538, 539, 540, 541, 542, 544, 545, 546, 548, 551. Part Number: AL20020000 (VariSource iX Afterloader

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)