Events

Alerte De Sécurité sur Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Optima MR450W; 80071260300 - Optima MR450W and Optima MR450W and GEM; 80071260134 Discovery MR750W 3.0T; 80071260116 - Discovery MR450. Risk class II, containing the table option: MR Surgical Suite II with model numbers: M8074SS, M8053SS and M0074SS.

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, Com. e Serv.; 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
    1712
  • Date
    2015-10-07
  • 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
    According to the manufacturer, the unexpected loss of function of the patient transfer mechanism may prevent the transfer of the patient from the MRI table to the surgical table. In this way, the occurrence of this failure can generate delays in the care and treatment of patients during surgical or interventional procedures.
  • Cause
    Unexpected loss of the function of the patient transfer mechanism that allows the patient to be transferred from the mri table to the surgical table. a complaint was made regarding the non-release of the transfer board from the table of resonance preventing the movement of the board towards the surgical table.
  • Action
    Parts / parts correction. The table can still be used. However, they should be aware of any problems related to the release of the table. If any failure is observed, a GE field engineer should be contacted to correct the problem. Action code: IMF 60885.

Device

Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Opti...

Manufacturer

GE Healthcare do Brasil, Com. e Serv.; GE MEDICAL SYSTEMS LLC.