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U.S. Department of Health and Human Services

Class 2 Device Recall Mevion

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 Class 2 Device Recall Mevionsee related information
Date Initiated by FirmDecember 16, 2016
Date PostedFebruary 02, 2017
Recall Status1 Terminated 3 on April 13, 2017
Recall NumberZ-1122-2017
Recall Event ID 76090
510(K)NumberK120676 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductMEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Code Information S250-0002 and S250-0003
FEI Number 3007087027
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster Street
Littleton MA 01460-2017
For Additional Information ContactSAME
978-540-1500
Manufacturer Reason
for Recall		An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
FDA Determined
Cause 2		Software design
ActionMevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.
Quantity in Commerce2 units
DistributionUS Nationwide in the states of OK, NJ
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 = LHN
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