Z-0152-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142 devices
Product Description
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, 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: 00802526584404, Serial numbers: 169280, 169298, 169494, 169753, 169776, 169934, 169941, 170003, 169547, 169151, 169315, 169514, 169851, 169879, 169292, 169696, 169786, 169788, 169852, 170002, 169400, 169405, 169898, 169973, 169885, 169335, 169233, 169608, 169304, 169410, 166452, 169278, 169319, 169321, 169651, 169688, 169864, 169920, 169235, 169277, 169834, 169472, 169417, 169202, 169329, 169426, 169511, 169529, 169630, 169757, 169963, 167092, 169236, 169301, 169310, 169316, 169393, 169436, 169485, 169537, 169543, 169565, 169567, 169571, 169579, 169582, 169599, 169601, 169606, 169663, 169771, 169238, 169323, 169680, 169270, 169265, 169372. UPN: 00802526581519, Serial numbers 169312, 169409, 169421, 169428, 169521, 169561, 169493, 169654, 169653, 169635, 169731, 169477, 169495, 169496, 169474, 169491, 169468, 169455, 169442, 169446, 169435, 169447, 168979, 169271, 169384, 169353, 169371, 169351, 169203, 169469, 169471, 169314, 169342, 169475, 169448, 169404, 169407, 169450, 169396, 169470, 169356, 169373, 169402, 169413, 169441, 169539, 169545, 169551, 169674, 169267, 169350, 169589, 169307, 169595, 169596, 169600, 169286, 169603, 169605, 169206, 169340, 169502, 169505, 169510, 169348.