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.
This recall has been terminated (originally issued June 26, 2015).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- May 18, 2015
- Posted
- June 26, 2015
- Terminated
- September 12, 2016
- Recall Number
- Z-1849-2015
- Quantity
- 55
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
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
Worldwide Distribution.
Lot / Code Info
JAQ
Root Cause
Software Design Change
Action Taken
All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.