FDA-Device2017-11-15Class II
RESONATE X4 CRT-D, Model G447, Sterile.
Boston Scientific Corporation
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-0081-2018Don't want to check this manually?
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