Class 2 Device Recall ARTISTE with syngo RT Therapist 4.3.1

• Date Initiated by Firm: November 09, 2022
• Date Posted: December 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0472-2023
• Recall Event ID: 91182
• 510(K)Number: K142434
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version; 4.3.1 MR3.; ; Material Number: 8162815; Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
• Code Information: UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3
• 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: When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
• FDA Determined Cause: Software design
• Action: Siemens issued Urgent Medical Device Correction Letter CSAN TH001/22/S to all affected customers on 11/09/2022. Letter states reason for recall, health risk and action to take: Siemens is developing the new syngo RT Therapist (RTT) software version RTT 4.3.1 MR4. With the new software version, the User will be able to load only one site at a time and avoid confusion of multiple displayed sites. If the User tries to download multiple sites from ARIA to syngo RT Therapist (RTT), the RTT will reject the complete patient load. If this occurs, User should immediately change their workflow by preparing one scheduler per planned site in ARIA. Availability of the new syngo RT Therapist (RTT) software version RTT 4.3.1 MR4 is currently unknown. Confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice by signing this document. Request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the ecommendations therein. Please ensure that this safety advisory is retained in your system Instructions for Use. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.
• Quantity in Commerce: 8 units US
• Distribution: US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.