Class 2 Device Recall Mevatron M2/Primus Mid Energy and PRIMUS HI

• Date Initiated by Firm: February 14, 2017
• Create Date: March 20, 2017
• Recall Status: Terminated on December 18, 2017
• Recall Number: Z-1489-2017
• Recall Event ID: 76712
• 510(K)Number: K993425
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Mevatron M2/Primus Mid-Energy PRIMUS HI
• Code Information: Device Model# 1940035, 4504200
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Marlynne Galloway; 610-448-6478
• Manufacturer Reason for Recall: Software update
• FDA Determined Cause: Software design
• Action: Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option.
• Quantity in Commerce: 80 systems
• Distribution: Distributed throughout the United States
• 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 = IYE