Siemens recalls ARTIS One Angiographic X-Ray Systems due to rare risk of higher radiation dose from incorrect copper prefiltration during x-ray releases. Affected units may require correction to prevent unintended radiation exposure.
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Siemens is recalling its ARTIS One Angiographic X-Ray Systems because a rare issue could cause higher radiation doses during x-ray releases. This might lead to unintended radiation exposure for patients if the system malfunctions.
The system may occasionally use incorrect copper prefiltration during the first x-ray release after patient registration. This can cause the radiation dose-rate to be higher than intended, potentially increasing radiation exposure for patients.
Patients using the ARTIS One X-Ray System for medical imaging may be at risk if the system malfunctions. Healthcare providers using these systems are most affected due to the medical context.
Check for the ARTIS One Angiographic X:Ray System with model number 10848600. This product was sold by Siemens Medical Solutions USA, Inc.
Reach out to Siemens Medical Solutions USA, Inc for guidance on whether your system is affected and next steps.
The recall describes a rare issue that could lead to higher radiation doses, but it is not a common or immediate hazard.
Check for the ARTIS One Angiographic X-Ray System with model number 10848600, as this is the specific product recalled.
Contact Siemens Medical Solutions USA, Inc for guidance on whether your system is affected and next steps.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0922-2025 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0922-2025 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.
