Company:Boston Scientific Corporation
Date of Enforcement Report: 10/31/2022
Class II
PRODUCT
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Recall Number:
Z-0151-2023
REASON
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc
VOLUME OF PRODUCT IN COMMERCE
7 devices
DISTRIBUTION
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.
