FDA-Device2015-07-08Class II
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Varian Medical Systems Inc
Hazard
After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).
Sold states
Worldwide Distribution.
Affected count
55
Manufactured in
501 Locust Ave, Charlottesville, VA, United States
Products
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2015Don't want to check this manually?
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