Z-0151-2023 Class II Ongoing
FDA device recall Z-0151-2023 was initiated by Boston Scientific Corporation on Sep 30, 2022 and is designated Class II. Reason for recall: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. The recall status is ongoing. Affected quantity: 7 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
Product Description
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason for Recall
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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.
Code Information
UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0151-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026