International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Event ID
I1404-161
Event Number
2007DM-0001028
Date
2014-04-24
Event Country
Colombia
Event Source
INVIMA
Event Source URL
https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=204
Notes / Alerts

Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
Extra notes in the data
Reason
The manufacturer informs about possible overheating of the equipment in the back part of the magnet tunnel, product of a deficiency in the electromechanical connection of the gradient coils, leading to the occurrence of adverse events on the patient.

Device

magnetic resonance equipment

Model / Serial
Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, Discovery MR750w equipped with the GEM option
Product Description
It uses an imaging technique that uses the magnetic properties of the atomic nuclei of the material (tissues, organs, bones, etc.). This signal that reflects the atoms is captured and translated into very precise images, which reveal a number of normal and abnormal anatomical situations that a trained professional can interpret for the diagnosis of different pathologies.
Manufacturer
GE Medical Systems, Llc. || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc (Dba Ge Healthcare) || Xinaomdt Technology Co, Ltd || GE Medical Systems Scs || General Medical Merate Spa || GE Healthcare || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda || GE Medical Systems Technologies Co Ltd || .

Manufacturer

GE Medical Systems, Llc. || GE Medical Systems Information Technologies Gmbh || GE Medical System...

Manufacturer Parent Company (2017)
General Electric Company
Source
NIDFSINVIMA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Safety Alert for magnetic resonance equipment

What is this?

Device

magnetic resonance equipment

Manufacturer

GE Medical Systems, Llc. || GE Medical Systems Information Technologies Gmbh || GE Medical System...