Reported Jul 8, 2015 · Terminated
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical…
Varian Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems Inc · 501 Locust Ave · Charlottesville, VA · 22902-4869
Is this the product you have?
- 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.
- Lot codes and dates
- JAQ
- Amount recalled
- 55
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).
This product could cause temporary or reversible health problems — stop using it.
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