# FDA recall Z-1113-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-03-21.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1113-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-21
- **Report date:** 2019-04-17
- **Termination date:** 2022-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2019

## Citation

> AI Analytics. FDA recall Z-1113-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1113-2019. Source: US FDA. Licensed CC0.

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