FDA Device recall Z-1849-2015
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placi…
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placi… by Varian Medical Systems, citing 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 issu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1849-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-18 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | n/a |
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).
Identifiers
| code_info | JAQ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Varian Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1849-2015%22
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