Company:Varian Medical Systems Inc
Date of Enforcement Report: 7/8/2015
Class lI:
PRODUCT
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. Recall Number Z-1849-2015
REASON
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).
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc., Charlottesville, VA on 5/18/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
55
DISTRIBUTION
Nationwide and Internationally
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