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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250 Radiation Treatment System

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 Class 2 Device Recall MEVION S250 Radiation Treatment Systemsee related information
Date Initiated by FirmJune 23, 2020
Create DateJuly 22, 2020
Recall Status1 Terminated 3 on December 09, 2020
Recall NumberZ-2686-2020
Recall Event ID 86028
510(K)NumberK120676 
Product Classification Instrument, quality-assurance, radiologic - Product Code LHO
ProductMEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Code Information Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008  UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
FEI Number 3007087027
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information ContactPing Hu
978-540-1500
Manufacturer Reason
for Recall		The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
FDA Determined
Cause 2		Device Design
ActionThis screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.
Quantity in Commerce8 units
DistributionMO, NJ, OK, FL, OH, DC, Netherlands
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 = LHO
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