FDA-Device2017-11-15Class II
MOMENTUM X4 CRT-D, Model G138, 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
4 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
MOMENTUM X4 CRT-D, Model G138, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2018Don't want to check this manually?
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