FDA-Device2022-11-09Class II
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Boston Scientific Corporation
Hazard
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sold states
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.
Affected count
142 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2023Don't want to check this manually?
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