Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; 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
    1827
  • Date
    2016-02-25
  • 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
    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.
  • Reason
    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...