Siemens recalls syngo.CT Cardiac Planning software (model 104961: VB20A/VB30A) due to potential wrong measurement in TAVI planning. This could affect cardiac surgery accuracy. Affected users should contact Siemens for details.
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 Planning software (model 10496180) because a software issue might cause incorrect measurements during TAVI (transcatheter aortic valve implantation) planning. This could lead to inaccurate cardiac surgery decisions if the software is used without the fix.
The software has a known issue in its TAVI algorithm that can cause incorrect measurements in the annulus plane. This might lead to inaccurate planning for transcatheter aortic valve implantation procedures, potentially affecting surgical outcomes.
Physicians using Siemens syngo.CT Cardiac Planning software for cardiac CT angiography analysis are most at risk. The recall affects users of specific software versions (VB20A or VB30A) for TAVI planning.
Check if you have Siemens syngo.CT Cardiac Planning software (model 10496180) with versions VB20A or VB30A. The software is used for cardiac CT angiography analysis and TAVI planning.
Reach out to Siemens Medical Solutions USA, Inc for specific guidance on the recall and next steps.
Yes, this software is used for cardiac CT angiography analysis and TAVI planning, which supports cardiac surgery decisions.
The affected versions are VB20A and VB30A of syngo.CT Cardiac Planning (model 10496180).
The software error could lead to incorrect measurements during TAVI planning, potentially affecting surgical accuracy and patient outcomes.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1113-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1113-2019 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.
