Events

Recall Or Safety Alert for Discovery MR450, Optima MR450w (with and without GEM), Discovery MR750, Optima MR360, Brivo MR355, Signa HDx, Signa HDxt, Signa Vibrant, Signa HDi, Signa HDe 1.5T, Ovation HD, and Profile HD

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by GE.

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.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2012-08-02
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possibility that the reformatted axial and coronal images of a 3D sagittal series of more than 126 cuts can show a flip of the image from left to right, when using certain magnetic resonance systems manufactured by GE

Device

Discovery MR450, Optima MR450w (with and without GEM), Discovery MR750, Optima MR360, Brivo MR355...
  • Model / Serial
  • Manufacturer
    GE

Manufacturer

GE