Siemens Healthcare recalls ARTIS Icono angiography systems with specific model numbers due to a rare risk of higher radiation doses during initial X-ray scans. 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 ARTIS Icono angiography systems with certain model numbers because a rare issue could cause higher radiation doses during the first X-ray scan after patient registration. This may lead to unintended radiation exposure, but the risk is very low and only affects specific models.
The issue involves a small detector and collimator in specific ARTIS Icono models. In very rare cases, the first X-ray release after patient registration might use incorrect copper prefiltration, leading to a higher-than-intended radiation dose rate. This could result in unintended radiation exposure during initial scans.
Patients and medical staff using Siemens ARTIS Icono systems with model numbers 10843101, 11327600, 11328100, or 11327700 are likely affected. Those performing imaging on pediatric or obese patients are at slightly higher risk due to the system's design.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on the ARTIS Icono systems. These models 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 10843101, 11327600, 11328100, or 11327700.
The recall is due to a rare issue where the first X-ray release after patient registration might use incorrect copper prefiltration, potentially leading to higher radiation doses than intended.
Check for model numbers 10843101, 11327600, 11328100, or 11327700 on your ARTIS Icono system. These specific models were identified in the recall.
No, the recall does not require stopping use. The issue is very rare and only affects specific models; the system can continue to be used safely with proper checks.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2241-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2241-2024 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.
