Date Initiated by Firm | May 18, 2015 |
Date Posted | June 26, 2015 |
Recall Status1 |
Terminated 3 on September 12, 2016 |
Recall Number | Z-1849-2015 |
Recall Event ID |
71451 |
510(K)Number | K122236 |
Product Classification |
System, applicator, radionuclide, remote-controlled - Product Code JAQ
|
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. |
Code Information |
JAQ |
Recalling Firm/ Manufacturer |
Varian Medical Systems Inc 501 Locust Ave Charlottesville VA 22902-4869
|
For Additional Information Contact | Rachel Forsberg 434-951-8635 |
Manufacturer 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 2 | 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 in Commerce | 55 |
Distribution | Worldwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAQ
|