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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 S250see related information
Date Initiated by FirmOctober 20, 2016
Date PostedNovember 15, 2016
Recall Status1 Terminated 3 on May 15, 2017
Recall NumberZ-0411-2017
Recall Event ID 75494
510(K)NumberK120676 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductMEVION S250 Product Usage: Proton Radiation Therapy System
Code Information Serial Numbers: S250-0001 through S250-0006
FEI Number 3007087027
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
ActionMevion 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 Commerce6 units
DistributionUS Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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