Siemens recalls syngo.CT Cardiac Function software (model 10496180) due to potential wrong measurements during TAVI planning. Affected software versions VA20A, VA30A, VB10A may cause inaccurate annulus plane measurements.
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Siemens is recalling its syngo.CT Cardiac Function software for possible inaccurate measurements during TAVI planning. This could lead to incorrect cardiac assessments if used without the fix.
The software has a known issue in its TAVI algorithm that may cause incorrect measurements in the annulus plane during TAV:VAVI planning procedures. This could lead to inaccurate cardiac assessments if the software is used without the fix.
Physicians using the software for cardiac CT angiography planning are most at risk. The recall affects users of specific software versions for cardiac evaluation.
Check if you have Siemens syngo.CT Cardiac Function software version VA20A, VA30A, or VB10A. The product is used for cardiac CT angiography planning and evaluation.
Identify your software version by checking the version number in the product documentation or software interface.
The software has a potential risk of wrong measurements during TAVI planning, but it is not immediately dangerous. The risk is addressed by the recall.
Check your software version. If you have versions VA20A, VA30A, or VB10A, contact Siemens for guidance on next steps.
The software may provide inaccurate measurements in the annulus plane during TAVI planning, which could affect cardiac assessment decisions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1112-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1112-2019 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.
