Siemens Healthcare recalls ARTIS Icono angiography systems with specific model numbers due to potential incorrect radiation dose rates in rare cases. Affected units may require correction to ensure safe imaging.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) 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 Healthcare is recalling certain ARTIS Icono angiography systems that could deliver higher radiation doses than intended in very rare situations. This risk is minimal but requires attention to ensure patient safety during imaging procedures.
In very rare cases, the first x-ray release after patient registration might use incorrect copper prefiltration. This could cause the radiation dose rate to exceed what the user intended, potentially increasing radiation exposure.
Medical facilities using ARTIS Icono systems with model numbers 10843101, 11327600, 11328100, or 11327700 are most at risk. Patients undergoing imaging procedures with these systems may be affected.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on ARTIS Icono systems. These units were sold with specific serial numbers listed in the recall notice.
Identify the model number on your ARTIS Icono system to see if it matches the recalled numbers: 10843101, 11327600, 11328100, or 11327700.
Siemens Healthcare identified a potential issue with ARTIS Icono systems equipped with a small detector and collimator (model # 10843101) that could result in higher radiation doses than intended in very rare situations.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on your ARTIS Icono system. These specific models were sold with the listed serial numbers.
The recall does not specify a remedy, so affected users should contact Siemens Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2240-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2240-2024 from Siemens Healthcare. 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.
