Emblem MRI S-icd recall: Software Issue
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Why was Emblem MRI S-icd recalled?
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 142 devices
- 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.
- Recall date
- November 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)