Recall Z-1113-2019 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
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 p
| Date | Mar 21, 2019 |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170221 | syngo.CT Cardiac Planning Siemens Healthcare GmbH, Apr 21, 2017 |