Recall – CT Image analysis software algorithm error

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/17/2019
Class II:


syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.

Recall Number: Z-1112-2019


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 Medical Solutions USA, Inc on 3/21/2019. Voluntary: Firm Initiated recall is ongoing.

112 total


US Nationwide

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