FDA-Device2016-09-07Class II
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Invivo Corporation
Hazard
A diode was inadvertently not assembled into the system, which may result in coil overheating
Sold states
WI
Affected count
3
Manufactured in
3545 SW 47th Ave, N/A, Gainesville, FL, United States
Products
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2688-2016Don't want to check this manually?
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