Class 2 Device Recall MEVION S250

• Date Initiated by Firm: November 18, 2015
• Date Posted: February 08, 2016
• Recall Status: Terminated 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
• FEI Number: 3007087027
• 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: 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