Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment
Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text explicitly states the defect 'could imply danger to the patient' but does not report any specific injuries, hospitalizations, or deaths. This aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ARTIS Icono Interventional Fluoroscopic X-Ray system due to a software problem in the DSA Roadmap application. The issue affects systems running software version VE20B. In rare cases, if the DSA acquisition starts while the C-Arm or table is moving, the resulting vessel map may be misaligned with the subtracted fluoroscopic image.
This misalignment could cause the user to rely on an incorrect visualization of the catheter relative to the vessel map, which the source text states could imply danger to the patient. The recall covers 100 units distributed worldwide, with 31 units distributed nationwide in the U.S.
Affected units include the ARTIS Icono biplane (model # 11327600) and ARTIS Icono Floor (model # 11327700). Specific serial numbers are listed in the agency's recall record. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software issue.
The recalled product
- Product
- ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
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