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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250i

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  Class 2 Device Recall MEVION S250i see related information
Date Initiated by Firm October 01, 2018
Create Date January 09, 2019
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-0705-2019
Recall Event ID 81751
510(K)Number K172848  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product MEVION S250i
Code Information DI: (01)00864366000124 Serial Number: S250i-0007
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-540-1500
Manufacturer Reason
for Recall		 Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.
Quantity in Commerce 1 unit
Distribution DC
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 = LHN and Original Applicant = Mevion Medical Systems
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