Home / Recalls / Invivo Corporation / Z-2688-2016

Z-2688-2016 Class II Terminated

Recalled by Invivo Corporation — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
September 7, 2016
Initiation Date
May 6, 2016
Termination Date
August 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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

Reason for Recall

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

Distribution Pattern

WI

Code Information

Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

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