The VariSource iX series afterloader systems are computer controlled… — Class II medical device recall Z-1849-2015
Terminated recall by Varian Medical Systems Inc, reported 2015-07-08. After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction gen
| Recall number | Z-1849-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems Inc, Charlottesville, VA, United States |
| Recall initiated | 2015-05-18 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2016-09-12 |
| Quantity | 55 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1849-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.