Date Initiated by Firm |
October 21, 2016 |
Date Posted |
November 15, 2016 |
Recall Status1 |
Terminated 3 on May 10, 2017 |
Recall Number |
Z-0410-2017 |
Recall Event ID |
75498 |
510(K)Number |
K120676
|
Product Classification |
System,planning,radiation therapy treatment - Product Code MUJ
|
Product |
MEVION S250
Product Usage: Proton Radiation Therapy System |
Code Information |
Serial Number: 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 |
Recovery of Incorrect Isocenter -operational change
|
FDA Determined Cause 2 |
Software Design Change |
Action |
Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at rcessac@mevion.com or by phone at (978) 540-1501. |
Quantity in Commerce |
6 units |
Distribution |
US Nationwide Distribution in the states of FL, MO, NJ, OH 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
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