Invivo product recalled over fire hazard

Recall date

May 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Invivo Corporation recalls Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.

Recall number

Z-2688-2016

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

WI

Why it was recalled

A diode was inadvertently not assembled into the system, which may result in coil overheating

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.