Events

Safety Alert for MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies to units of the following GE Healthcare IRM systems: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T , Signa Excite 3.0T, Signa Contour / I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa Profile and Signa Ovation.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; GE Medical Systems, LLC.

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
    Safety alert
  • Event ID
    1540
  • Date
    2015-03-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Failure to update the software may result in errors in image orientation. Errors of this nature may result in inaccuracy in treatment.
  • Reason
    As described by the company "as of 12/11/2014 ge healthcare became aware that the latest version of the equipment's current software may not have been reinstalled in some facilities after performing maintenance services that require the software to be recharged . the latest implemented version of the software may include security updates. ".
  • Action
    According to company information, all affected systems will be inspected and ensured that the appropriate version of the software is installed, free of charge. The systems that allow this action will be checked remotely (online), and will visit the establishments where remote verification is unavailable.

Device

MAGNETIC RESONANCE IMAGE SYSTEM, Models and records: SEE CUSTOMER LETTER. ///. This fix applies t...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems, LLC