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U.S. Department of Health and Human Services

Class 2 Device Recall SYNGO.CT CARDIAC FUNCTION

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  Class 2 Device Recall SYNGO.CT CARDIAC FUNCTION see related information
Date Initiated by Firm March 21, 2019
Create Date April 09, 2019
Recall Status1 Terminated 3 on January 11, 2022
Recall Number Z-1112-2019
Recall Event ID 82517
510(K)Number K110366  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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.
Code Information Software versions VA20A, VA30A or VB10A
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = SIEMENS AG
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