Alerta De Seguridad para Trade name: Ultrasound System (ANVISA Registration 80035360066); LOGIQ 9 (ANVISA Registry 80035360066); LOGIQ E9 (ANVISA registration 80071260213); Vivid 7 (ANVISA registry 80071260187); Vivid E9 (ANVISA registration 80071260207); Vivid E80, Vivid E90 and Vivid E95 (ANVISA registration 80071260361). Technical Name: Ultrasound System. ANVISA registration number: 80035360066; 80071260213; 80071260187; 80071260207; 80071260361 .. Class of risk: II. Affected model: Logiq 9. Affected batches / series numbers: equipment installed since April 2015 or have been replaced with power cable since April 2015.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Company recommendations: Continue using your system. If you need to remove the power cord from the back of the unit before doing so, do the following: 1. Turn off the system. 2. Unplug the machine from the wall If the end of the power cord system is damaged, system until a replacement cable is supplied. If you experience power problems with your unit, stop using the system and contact GEHC Service. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 08/03/2018 - Date of notification notice to Anvisa: 05/02/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    It has been identified that the side of the power cable system can break and expose the electric conductors, with risk of shock. this can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. a mild injury was reported as a result of this problem.
  • Acción
    Field Action Code IMF 70219 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Field correction and communication sending to affected clients.