Date Initiated by Firm |
October 31, 2016 |
Date Posted |
November 15, 2016 |
Recall Status1 |
Terminated 3 on June 29, 2017 |
Recall Number |
Z-0409-2017 |
Recall Event ID |
75496 |
510(K)Number |
K120676
|
Product Classification |
System,planning,radiation therapy treatment - Product Code MUJ
|
Product |
MEVION S250
Product Usage: Proton Radiation Therapy |
Code Information |
Serial NUmbers: S250-0001 through S250-0006 |
Recalling Firm/ Manufacturer |
Mevion Medical Systems, Inc. 300 Foster Street Littleton MA 01460-2017
|
For Additional Information Contact |
978-540-1500
|
Manufacturer Reason for Recall |
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
|
FDA Determined Cause 2 |
Software design |
Action |
Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com |
Quantity in Commerce |
6 units |
Distribution |
US Nationwide in the states of FL, MO, NJ and OK |
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 = MUJ and Original Applicant = MEVION MEDICAL SYSTEMS
|