Siemens recalls ARTISTE, ONCOR and PRIMUS radiation therapy systems with software version 4.3.1 MR3 due to risk of delivering radiation to the wrong body site during cancer treatment. Affected units have specific serial numbers and material numbers.
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
Siemens is recalling ARTISTE, ONCOR, and PRIMUS radiation therapy systems with software version 4.3.1 MR3. This software version may cause the system to select the wrong treatment site, potentially delivering radiation to the incorrect body area during cancer treatment.
The software version 4.3.1 MR3 may cause the system to select the wrong body site for radiation treatment. This could lead to delivering radiation to an unintended area, potentially causing unnecessary tissue damage or treatment complications.
Healthcare providers using Siemens radiation therapy systems with specific serial numbers and software version 4.3.1 MR3 are affected. Patients receiving cancer treatment with these systems may be at risk if the software error occurs.
Check for serial numbers 10736, 10737, 10822, 10850, 10886, 10843, 10865, or 10025 on the system. The software version must be 4.3.1 MR3 with material number 8162815.
Verify the software version is 4.3.1 MR3 and the material number is 8162815.
The recalled software version is 4.3.1 MR3.
Affected serial numbers include 10736, 10737, 10822, 10850, 10886, 10843, 10865, and 10025.
The recall record does not mention any remedy or fix for this software version.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0472-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0472-2023 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
