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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 21, 2016
Date PostedNovember 15, 2016
Recall Status1 Terminated 3 on May 10, 2017
Recall NumberZ-0410-2017
Recall Event ID 75498
510(K)NumberK120676 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductMEVION S250 Product Usage: Proton Radiation Therapy System
Code Information Serial Number: 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		Recovery of Incorrect Isocenter -operational change
FDA Determined
Cause 2		Software Design Change
ActionMevion 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 Commerce6 units
DistributionUS Nationwide Distribution in the states of FL, MO, NJ, OH and 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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