Class 2 Device Recall MEVION S250

• Date Initiated by Firm: March 15, 2016
• Date Posted: April 20, 2016
• Recall Status: Terminated on August 24, 2017
• Recall Number: Z-1529-2016
• Recall Event ID: 73602
• 510(K)Number: K120676
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: MEVION S250 for Proton Radiation Therapy
• Code Information: S250-0002
• Recalling Firm/ Manufacturer: Mevion Medical Systems, Inc.; 300 Foster Street; Littleton MA 01460-2017
• For Additional Information Contact: 978-540-1751
• Manufacturer Reason for Recall: Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
• FDA Determined Cause: Device Design
• Action: Customer notification letters were sent to customers on March 15, 2016, by certified mail, return receipt requested, as well as by email. The letter explains the problem, description of potential harm, and the cause containment, and mitigation. The cause of the malfunctioning sensors was discovered to be a non-conforming limit switch assembly. A Mevion Field Service Engineer will immediately inspect all such parts in the field for similar non-conformance, and replace those parts if necessary. In addition, a new periodic preventive maintenance check will be performed to individually test each of the redundant sensors at all sites. In the interim period, on a daily basis, until the inspection, repair, and the preventive maintenance check is completed at any site, Mevion Field Service will check that the Applicator Door interlock sensors are working properly. Mevion will also update the inspection procedure for incoming parts to ensure that any non-conformance is identified early in the manufacturing process.
• Quantity in Commerce: 5
• Distribution: US nationwide distribution to MO, OK, FL, and 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