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Boston Scientific Corporation recalls RESONATE X4 CRT-D, Model G447, Sterile.
Recalled November 15, 2017 · FDA recall Z-0081-2018 · Boston Scientific
Hazard
The devices have an incorrect firmware configuration. · FDA Class II
Units
11 devices
Sold at
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Description
The devices have an incorrect firmware configuration.
Product
RESONATE X4 CRT-D, Model G447, Sterile.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →