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Recall Observatory FDA recall evidence

Device product

EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Z-0151-2023

September 30, 2022

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 90985
Status
Ongoing
Classification
Class II
Quantity
7 devices
Official record key
device-enforcement:Z-0151-2023

Official wording

Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Code information: UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    incorrect manufacturing date/timestamp within the software