Company:Boston Scientific Corporation
Date of Enforcement Report: 10/31/2022
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Siemens Medical Solutions USA, Inc
VOLUME OF PRODUCT IN COMMERCE
Worldwide distribution – US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.