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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250

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  Class 2 Device Recall MEVION S250 see related information
Date Initiated by Firm October 20, 2016
Date Posted November 15, 2016
Recall Status1 Terminated 3 on May 15, 2017
Recall Number Z-0411-2017
Recall Event ID 75494
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 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		 Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
FDA Determined
Cause 2		 Software design
Action Mevion issued an Important Safety Notice letter on October 14, 2016 to their customers. The letter identified the affected product, problem, containment, mitigation and actions taken. Customers were informed that Mevion will be updating software when it is released. For further Information, contact: srosenthal@mevion.com.
Quantity in Commerce 6 units
Distribution US Nationwide Distribution in the states of: FL, MO, NJ, OH, 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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