FDA-Device2017-11-15Class II
RESONATE X4 CRT-D, Model G447, Sterile.
Hazard
The devices have an incorrect firmware configuration.
Sold states
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Affected count
11 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
RESONATE X4 CRT-D, Model G447, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2018More Boston Scientific Corporation recalls
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