Z-1113-2019Class II

syngo.via syngo.CT Cardiac Planning, Model Number 10496180

Name: Z-1113-2019 syngo.via syngo.CT Cardiac Planning, Model Number 10496180
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-03-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-03-21 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software... on 2019-03-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1113-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-21
Posted: 2019-04-09
Terminated: 2022-01-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo.via syngo.CT Cardiac Planning, 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Customer Safety Advisory Notice letters dated 3/20/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-888-7436.
Quantity in commerce: 112 total
Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Software versions VB20A or VB30A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1113-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-09
Z-1113-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-09

Product code JAK

K170221Class IIsyngo.CT Cardiac PlanningSiemens Healthcare GmbH / cleared 2017-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)