—#190892

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142434
Affected lot / code info: Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.

Timeline

Recall initiated: 2021-12-09
Terminated: 2023-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.