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 prevent higher-than-intended radiation exposure.
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 specific ARTIS Icono angiography systems that could have incorrect radiation dose rates in rare situations. This could lead to higher radiation exposure than intended, though the risk is very low.
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 be higher than 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 procedures with these systems may be affected.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on ARTIS Icono systems. These systems were sold with specific serial numbers in the United States.
Identify the model number on your ARTIS Icono system to see if it matches the recalled numbers.
In very rare situations, the first x-ray release after patient registration may use incorrect copper prefiltration, potentially causing higher radiation dose rates than intended.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on your ARTIS Icono system.
No, the recall does not require stopping use; affected systems may continue to be used with monitoring.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2242-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2242-2024 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.
