Recall Z-2688-2016— Invivo Corporation

Name: FDA recall Z-2688-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-06

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2016-05-06, terminated 2019-08-21. It names one FDA 510(k) clearance: K100113. Product: Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.. Reason: A diode was inadvertently not assembled into the system, which may result in coil overheating.

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Terminated: 2019-08-21
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K100113 — VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51Sentinelle Medical, Inc.·cleared 2010-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.