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U.S. Department of Health and Human Services

Class 2 Device Recall Mevion S250 Proton Therapy System

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  Class 2 Device Recall Mevion S250 Proton Therapy System see related information
Date Initiated by Firm February 01, 2022
Create Date March 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-0827-2022
Recall Event ID 89758
510(K)Number K120676  K172848  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Code Information All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact Mevion Customer Service
978-540-1500
Manufacturer Reason
for Recall		 Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
FDA Determined
Cause 2		 Component design/selection
Action Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service (robyn.walker@mevion.com) with any questions or concerns.
Quantity in Commerce 39 (36 US, 3 OUS)
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LHN and Original Applicant = MEVION MEDICAL SYSTEMS
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