Recall Z-1849-2015— Varian Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems Inc, initiated 2015-05-18, terminated 2016-09-12. It names one FDA 510(k) clearance: K122236. 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.. 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
- Varian Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-18
- Terminated
- 2016-09-12
- Firm location
- Charlottesville, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.