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Recall Observatory FDA recall evidence

Device 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.

Z-1849-2015

May 18, 2015

Class II

Product summary

Firm
Varian Medical Systems Inc
Event
Event 71451
Status
Terminated
Classification
Class II
Quantity
55
Official record key
device-enforcement:Z-1849-2015

Official wording

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).

Code information: JAQ

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).