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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 System see related information
Date Initiated by Firm June 23, 2020
Create Date July 22, 2020
Recall Status1 Terminated 3 on December 09, 2020
Recall Number Z-2686-2020
Recall Event ID 86028
510(K)Number K120676  
Product Classification Instrument, quality-assurance, radiologic - Product Code LHO
Product MEVION 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
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact Ping 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
Action This 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 Commerce 8 units
Distribution MO, NJ, OK, FL, OH, DC, Netherlands
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 = LHO and Original Applicant = MEVION MEDICAL SYSTEMS
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