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FDA (Device enforcement)Recalled 2022-09-30class ii

Boston Scientific Corporation: EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

Hazard

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

Details from the source

Reason for recall: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. Distribution: 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. Quantity: 142 devices Lot/code info: 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.

UPC codes

00802526584404, 00802526581519

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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