Siemens Medical Solutions USA, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886, 10843, 10865, 10025 Software version 4.3.1 MR3
Products Sold
UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3
Siemens Medical Solutions USA, Inc is recalling ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number due to When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isoc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026