Siemens recalls ARTIS pheno and Icono biplane x-ray systems for potential sporadic dose increases during patient exams. Actual doses remain within regulatory limits but may cause unnecessary radiation exposure.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Siemens is recalling certain ARTIS pheno and Icono biplane x-ray systems due to sporadic increases in reported x-ray dose during patient exams. While actual doses stay within regulatory limits, this could lead to unnecessary radiation exposure for patients.
The system may temporarily show higher x-ray dose readings during patient exams. However, the actual radiation delivered remains within regulatory limits. This could result in unnecessary radiation exposure for patients.
Patients using these specific Siemens x-ray systems during medical exams may be exposed to unnecessary radiation. Healthcare facilities that own or use these models are most at risk.
Check for model numbers 10849000, 11327600, 11328100, or 11327700 on the device. The unique device identifiers (UDIs) are also listed in the recall notice.
Identify the model number on your Siemens ARTIS pheno or Icono biplane x-ray system to confirm if it's affected.
The recall indicates potential sporadic increases in reported x-ray dose during exams, but actual radiation levels remain within regulatory limits. This could lead to unnecessary exposure but is not immediately hazardous.
Check for model numbers 10849000, 11327600, 11328100, or 11327700 on your device. The unique device identifiers (UDIs) are also listed in the recall notice.
No action is required for the system to continue operating. The recall does not mandate stopping use but requires checking model numbers.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1653-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1653-2026 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.
