FDA-Device2022-11-09Class II
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, 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
7 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0151-2023Don't want to check this manually?
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