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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 FirmNovember 10, 2014
Date PostedDecember 12, 2014
Recall Status1 Terminated 3 on March 18, 2015
Recall NumberZ-0588-2015
Recall Event ID 69778
510(K)NumberK120676 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductMEVION S250, used for proton radiation therapy.
Code Information Serial Number: S250-0001
FEI Number 3007087027
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information ContactThomas H. Faris
978-540-1500
Manufacturer Reason
for Recall		Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
FDA Determined
Cause 2		Software design
ActionMevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email lbouchet@mevion.com or call 978-540-1555.
Quantity in Commerce1
DistributionUS Distribution in the state of MO
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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