Siemens recalls Artis pheno and icono CT systems with syngo VE20 software (Material 10848815) due to potential patient misorientation after Toshiba CT data loading. Affected units may require software update.
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
Siemens is recalling the syngo VE20 software (Material Number 10848815) for Artis pheno and Artis icono CT systems. This software can cause image mirroring along horizontal and vertical axes after loading Toshiba CT data, potentially misinterpreting patient orientation and leading to incorrect treatments.
After loading CT image data from Toshiba, the software can mirror images horizontally and vertically. This may cause the system to misinterpret patient orientation, leading to inappropriate medical treatments even when the incorrect visualization appears obvious to the user.
Healthcare facilities using Siemens Artis pheno or Artis icono CT systems with the specific syngo VE20 software version (Material Number 10848815) are affected. Patients undergoing CT scans with these systems may be at risk of incorrect treatment if image mirroring occurs.
Check for the syngo VE20 software version (Material Number 10848815) installed on Artis pheno (Model 10849000), Artis icono biplane (Model 11327600), or Artis icono floor (Model 11327700) systems. The serial numbers listed in the recall include specific combinations starting with 170319, 180062, etc.
Verify if your Artis pheno or icono CT system has the syngo VE20 software version (Material Number 10848815) by checking the model numbers and serial numbers listed in the recall.
The software can cause image mirroring along horizontal and vertical axes after loading Toshiba CT data, potentially misinterpreting patient orientation and leading to inappropriate treatments.
Artis pheno (Model 10849000), Artis icono biplane (Model 11327600), and Artis icono floor (Model 11327700) systems with syngo VE20 software version (Material Number 10848815).
No, the recall does not require immediate discontinuation. Affected users should check their software version and contact Siemens for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1339-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1339-2022 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.
