Z-0441-2022Class II

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for...

Name: Z-0441-2022 ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-12-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-12-09 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model... on 2021-12-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0441-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-09
Posted: 2021-12-29
Terminated: 2023-05-04
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: IYE Accelerator, Linear, Medical
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 root 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.
Product codes and lots: Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0441-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-05	2021-12-29

Product code IYE

K142434Class IIArtiste Solution, Sys_vc10c, Phase 2 Update with the Syngo Rt Therapist & Rt Oncologist Workspaces, V4.3.1_mr1Siemens Medical Solutions USA, Inc. / cleared 2014-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)