Events

Alerte De Sécurité sur Discovery MR 750 3.0T model Discovery MR 750 3.0T, registration 80071260110 and Image and Magnetic Resonance Imaging System, Discovery MR 750w 3.0T model, registration 80071260134, hazard class II, lot / series 0000040-4-0161; 0000033-4-0161; 0000034-4-0152; 000032E-4-0181; 0000040-4-0146; 0000033-4-0145; 0000034-4-0139; 000032E-4-0160; 0000040-4-0258; 0000033-4-0261; 0000034-4-0242; 000032E-4-0313; 0000004-4-0242; 0000040-4-0439; 0000033-4-0443; 000032E-4-0554.

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 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
    1827
  • Date
    2016-02-25
  • 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
    This problem was observed by GE Healthcare of Brazil in various coil configurations and port connections. To avoid this problem, follow the user's instructions on proper use of the pad to avoid all direct patient contact with the cable. The system may continue to be used. The user should ensure the following precautions as described in the GEM Flex 3.0T User Manual: - Placing the foam cover over the Interface. - Do not let the cable contact the patient. Use the cushion to prevent the cable from touching the patient. - Keep the shortest cable length in the gantry. - Use the system only in adult patients. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Cause
    On december 18, 2015, ge became aware of a safety problem related to the gemflex 3.0t coil, manufactured by neocoil, used in ge healthcare's 3.0t magnetic resonance equipment. part of the cable assembly may overheat while using the device. the occurrence of this problem could result in a burn, which according to the holder of the record is of minimal degree, in the case of prolonged contact of the skin with the superheated part.
  • Action
    IMF Action Code 60891. Notification to Customers-Delivery of Urgent Security Notice Letters issued on 02/25/2016 /// Recommendations to Users and Patients: To avoid this problem, follow the user's instructions on proper use of the cushion (pad), to avoid any direct contact of the patient with the cable. The system may continue to be used. The user should ensure the following precautions as described in the GEM Flex 3.0T User Manual: - Placing the foam cover over the Interface. - Do not let the cable contact the patient. Use the cushion to prevent the cable from touching the patient. - Keep the shortest cable length in the gantry. - Use the system only in adult patients. //// Field Correction - Parts and Parts Correction .///// If you have questions about this action or the identification of the affected items, please contact your local GE Healthcare Sales or Service representative. Please call the following number: 0800-122345

Device

Discovery MR 750 3.0T model Discovery MR 750 3.0T, registration 80071260110 and Image and Magneti...

Manufacturer

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