Z-0472-2023Class II

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815

Name: Z-0472-2023 ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-11-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-11-09 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2022-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0472-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-09
Posted: 2022-12-09
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: software
FDA root 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.
Product codes and lots: UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0472-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0472-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-09

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)