FDA-Device2017-11-15Class II
RESONATE EL ICD DR, Model D433, 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
12 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
RESONATE EL ICD DR, Model D433, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2018Don't want to check this manually?
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