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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250

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  Class 2 Device Recall MEVION S250 see related information
Date Initiated by Firm October 31, 2016
Date Posted November 15, 2016
Recall Status1 Terminated 3 on June 29, 2017
Recall Number Z-0409-2017
Recall Event ID 75496
510(K)Number K120676  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product MEVION S250

Product Usage: Proton Radiation Therapy
Code Information Serial NUmbers: S250-0001 through S250-0006
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster Street
Littleton MA 01460-2017
For Additional Information Contact
978-540-1500
Manufacturer Reason
for Recall		 Completing Setup Without Program Move Complete Can Cause An Isocenter Error
FDA Determined
Cause 2		 Software design
Action Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com
Quantity in Commerce 6 units
Distribution US Nationwide in the states of FL, MO, NJ and OK
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 = MUJ and Original Applicant = MEVION MEDICAL SYSTEMS
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