Class 2 Device Recall Siemens

• Date Initiated by Firm: December 09, 2021
• Create Date: December 29, 2021
• Recall Status: Terminated on May 04, 2023
• Recall Number: Z-0441-2022
• Recall Event ID: 89228
• 510(K)Number: K142434
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
• Code Information: Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
• FDA Determined Cause: Other
• Action: Siemens issued Urgent Medical Device Corrction Letter CSAN TH001/21/S on 12/09/2021 to inform them of the potential issue and associated risk. Acton to take: 1. Carefully verify all planned treatment parameters against those actually set during patient setup before treating a patient. 2. Choose one of the following workflow options: - Use absolute table positions. In this case, positioning on a different isocenter would not match the planned table values and the system would prompt an override request. This minimizes the risk of selecting a wrong site fraction group. Or - In the case of mulitple sites, select and download one site at a time from ARIA. In this case, RTT would only display one site. Or - Create a multiple isocenter plan in ARIA. RTT cross checks table positions and selected isocenter coordinates. Siemens also recommends consulting the your system s Instructions for Use, Chapter 3.3.4, One treatment plan divided into two plans . The workflow described in this section prevents the occurrence of the reported incident. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understood the content therein. Siemens Healthineers is not planning a correction for this (potential) issue. The intent of this Customer Safety Advisory Notification is to remind you of the importance to diligently verify the correct treatment parameters when multiple sites get loaded into the RT Therapist.
• Quantity in Commerce: 13 units
• Distribution: US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
• 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