Events

Alerte De Sécurité sur Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equipment ANVISA Registration Number: 80071260352 Hazard Class: II Model Affected: Signa Creator; Signa Explorer Affected Serial Numbers: Signa Creator and Signa Explorer Equipment

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. para Equipamentos Médico-Hospitalares Ltda.; GE Healthcare (Tianjin) Company Limited e GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda..

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
    2139
  • Date
    2016-09-09
  • 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
    You may continue to use the system, but you must ensure that the RF power monitor is reactivated when starting a new patient examination if a redefinition of TPS has been performed during the patient examination. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Cause
    The function of the rf power monitor is to monitor the output power of the rf amplifier and to detect if the power of the rf transmission exceeds the expected amount that is generated. if the output power of the rf amplifier exceeds the specified sar (specific absorption rate), the rf power monitor will stop scanning. ge healthcare has identified that if the user performs a tps (transceiver processing and storage) reset during patient scanning, the rf power monitor is disabled for the remainder of this patient scan. this prevents the power monitor from detecting any subsequent failure of the rf transmission function.
  • Action
    Field Action Code IMF 67921 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equ...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Healthcare ...