Recall Z-1849-2015
Varian Medical Systems Inc · initiated May 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: JAQ
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).
FDA-determined 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.
Details
- Recall number
- Z-1849-2015
- Initiated
- May 18, 2015
- Posted by FDA
- June 26, 2015
- Terminated
- September 12, 2016
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 55
- Distribution
- Worldwide Distribution.
- Recalling firm
- Varian Medical Systems Inc, Charlottesville, VA