Z-1849-2015 Class II Terminated
FDA device recall Z-1849-2015 was initiated by Varian Medical Systems Inc on May 18, 2015 and is designated Class II. 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 s… The recall status is terminated (terminated September 12, 2016). Affected quantity: 55.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- May 18, 2015
- Termination Date
- September 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55
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).
Distribution Pattern
Worldwide Distribution.
Code Information
JAQ