Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par GE Healthcare do Brasil; GE Medical Systems, LLC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1540
  • Date
    2015-03-13
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Failure to update the software may result in errors in image orientation. Errors of this nature may result in inaccuracy in treatment.
  • Cause
    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