Recall- Incorrect Manufacturing Date within Software Causes Inaccurate Battery Capacity Display

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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