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.
FDA Recall Z-0325-2012 · Posted 2011-12-01
Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated2010-03-01
Date Terminated2013-05-30
Product Quantity72 worldwide/50 in U.S.
Reason for Recall
VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.