Varian Medical Systems Inc recalls The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical…

Recall date

May 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1849-2015

FDA classification

Class II

Brand / firm

Varian Medical Systems Inc

Sold / distributed

Worldwide Distribution.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.