Class 2 Device Recall Mevion

• Date Initiated by Firm: December 16, 2016
• Date Posted: February 02, 2017
• Recall Status: Terminated on April 13, 2017
• Recall Number: Z-1122-2017
• Recall Event ID: 76090
• 510(K)Number: K120676
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: MEVION S250-Proton Radiation Therapy; ; Product Usage:; Proton Radiation Therapy
• Code Information: S250-0002 and S250-0003
• Recalling Firm/ Manufacturer: Mevion Medical Systems, Inc.; 300 Foster Street; Littleton MA 01460-2017
• For Additional Information Contact: SAME; 978-540-1500
• Manufacturer Reason for Recall: An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
• FDA Determined Cause: Software design
• Action: Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.
• Quantity in Commerce: 2 units
• Distribution: US Nationwide in the states of OK, NJ
• 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