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Terminated

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

FDA Recall Z-2688-2016 · Posted None

Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMOS
Date Initiated2016-05-06
Date Terminated2019-08-21
Product Quantity3

Reason for Recall

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

Root Cause

Under Investigation by firm

Distribution Pattern

WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100113VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51Sentinelle Medical, Inc. · 2010-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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