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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 November 18, 2015
Date Posted February 08, 2016
Recall Status1 Terminated 3 on April 03, 2017
Recall Number Z-0767-2016
Recall Event ID 72210
510(K)Number K120676  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product MEVION S250 Radiation therapy system
Code Information Manufacturing Lot or Serial Number: S250-0004
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster Street
Littleton MA 01460-2017
For Additional Information Contact
636-485-4962
Manufacturer Reason
for Recall		 The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
FDA Determined
Cause 2		 Labeling design
Action Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
Quantity in Commerce 4
Distribution US nationwide distribution including FL, NJ, OK, and MO.
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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