Siemens recalls ARTIS Icono Interventional Fluoroscopic X-Ray systems with software version VE20B due to a rare risk of incorrect catheter visualization during procedures, potentially endangering patients.
There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.
Siemens is recalling ARTIS Icono and ARTIS Pheno X-ray systems with software version VE20B. In rare cases, moving the C-Arm or table during a procedure could cause the system to display an inaccurate catheter position relative to blood vessels, which might lead to patient injury.
The software problem affects the DSA Roadmap application on specific X-ray systems. When the C-Arm or table moves during a procedure, the system may display a catheter position that doesn't match the actual blood vessel map, potentially causing incorrect treatment decisions.
Healthcare providers using Siemens ARTIS Icono or ARTIS Pheno systems with software version VE20B are most at risk. Patients undergoing procedures with these systems could face incorrect catheter placement if the software issue occurs.
Check for the ARTIS Icono biplane model #11327600 or ARTIS Icono Floor model #11327700. Serial numbers listed in the recall include 170023 through 180072 (excluding 180071).
Verify the software version on your system; affected units have version VE20B.
Reach out to Siemens directly for guidance on whether your system needs correction.
Check for the ARTIS Icono biplane model #11327600 or ARTIS Icono Floor model #11327700 with serial numbers listed in the recall (170023 through 180072).
The recall does not specify a fix; users should contact Siemens for guidance.
In rare cases, the software issue could lead to incorrect catheter visualization, potentially causing patient injury.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0400-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0400-2021 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.
