Siemens recalls ARTIS icono systems with Quantification Application SW (QVA/QCA) on standalone XWP computers. Using these may cause incorrect vessel detection and diagnosis, leading to inappropriate patient treatment.
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
Siemens is recalling ARTIS icono X-ray systems with specific software that may cause incorrect vessel detection during procedures. This could lead to wrong diagnoses and inappropriate treatments for patients.
The Quantification Application software (QVA/QCA) on standalone XWP computers can fail to detect blood vessels properly during imaging. This might cause the system to give incorrect measurements, leading to wrong treatment decisions for patients.
Healthcare providers using Siemens ARTIS icono systems with the Quantification Application SW (QVA/QCA) on standalone XWP computers are affected. Patients undergoing procedures with these systems may be at risk of incorrect diagnoses.
Check for model number 11327600 or serial numbers 180014, 180015, 180018, 180019, 180029 on the system. These systems were sold with the Quantification Application SW (QVA/QCA) on a standalone XWP computer.
Verify if your system has the Quantification Application SW (QVA/QCA) installed on a standalone XWP computer.
The model number is 11327600.
Serial numbers 180014, 180015, 180018, 180019, and 180029 are affected.
Check for the model number 11327600 or the listed serial numbers on your system with the Quantification Application SW (QVA/QCA) on a standalone XWP computer.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2257-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2257-2020 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.
