Z-1112-2019 Class II Terminated
FDA device recall Z-1112-2019 was initiated by Siemens Medical Solutions USA, Inc on March 21, 2019 and is designated Class II. 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. The recall status is terminated (terminated January 11, 2022). Affected quantity: 112 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- March 21, 2019
- Termination Date
- January 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 total
Product Description
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.
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 Pattern
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.
Code Information
Software versions VA20A, VA30A or VB10A