Events

Recall of Device Recall Sentinelle Vanguard Breast MRI , Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE1 .5/3T

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invivo Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74064
  • Event Risk Class
    Class 2
  • Event Number
    Z-2688-2016
  • Event Initiated Date
    2016-05-06
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146139
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coil, magnetic resonance, specialty - Product Code MOS
  • Reason
    A diode was inadvertently not assembled into the system, which may result in coil overheating.

Device

Device Recall Sentinelle Vanguard Breast MRI , Auxiliary Table/Tabletop with 8/16 Channel Coil A...
  • Model / Serial
    Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    WI
  • Product Description
    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Manufacturer Address
    Invivo Corporation, 3545 SW 47th Ave, Gainesville FL 32608-7691
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA