Recall Z-1849-2015 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems Inc
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.
| Date | Jun 26, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| 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). |
| Root cause | Software Design Change |
| Action | 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. |
| Quantity | 55 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122236 | VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER Varian Medical Systems, Inc., Nov 16, 2012 |