Date Initiated by Firm |
May 07, 2015 |
Date Posted |
July 02, 2015 |
Recall Status1 |
Terminated 3 on February 04, 2016 |
Recall Number |
Z-1954-2015 |
Recall Event ID |
71505 |
510(K)Number |
K111862
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
Treatment Planning and Delivery System Software version 3.6. ViewRay.
Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
Code Information |
Catalog/Part Number: 10000; Serial #'s: 100, 101, and 102 |
Recalling Firm/ Manufacturer |
Viewray Incorporated 2 Thermo Fisher Way Oakwood Village OH 44146-6536
|
For Additional Information Contact |
Mr. James Talbot 650-252-0949
|
Manufacturer Reason for Recall |
The software was failing to determine new patient locations if imaging is not enabled during treatment.
|
FDA Determined Cause 2 |
Software design |
Action |
On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers. |
Quantity in Commerce |
3 |
Distribution |
Distributed in the states of CA, MO & WI. |
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 = IYE and Original Applicant = VIEWRAY INCORPORATED
|