Alerta De Seguridad para Trade Name: Gyroscan ACS NT. Technical Name: Magnetic Resonance Equipment. Model: N / A. Registration / Registration: 10216710012. Risk Class: II. . Trade Name: Gyroscant 10 NT. Technical Name: Magnetic Resonance Equipment. Model: N / A. Registration / Registration: 10216710015. Risk Class: II. . Trade Name: Gyroscan T5 NT. Technical Name: Magnetic Resonance Equipment. Model: N / A. Registration / Registration: 10216710020. Risk Class: II. . Trade Name: Magnetic Resonance Imaging Equipment - INTERA. Technical Name: Magnetic Resonance Equipment. Model: Intera 1.0T; Intera 1.5 T. Registration / Registration: 10216710194. Class of Risk: II. . Trade Name: Achieva. Technical Name: Magnetic Resonance Equipment. Model: Achieva 1.5T, Achieva 3.0T and Achieva XR. Registration / Registration: 10216710205. Risk Class: II. . Trade Name: Ingenia. Technical Name: Magnetic Resonance Equipment. Model: Ingenia 1.5T / Ingenia 3.0T / Ingenia 1.5 T CX / Ingenia 3.0 T CX / Ingenia S 1.5T. Registration / Registration: 10216710217. Risk Class: II. . Commercial Name: Magnetic Resonance Equipment. Technical Name: Magnetic Resonance Equipment. Model: Multiva 1.5T. Registration / Registration: 10216710293. Class of Risk: II. . Batch number: See attached list

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V..

¿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
    During a quench, a large amount of helium gas evaporates and is vented out of place through a ventilation system. A quench causes immediate loss of the static magnetic field. A quench may occur spontaneously or may be induced if there is an emergency. If helium gas escapes to the examination room during a quech, ensure a strict adherence to the Instructions for Use: Release of helium gas in the examination room: If the helium gas is not properly vented out of place after the button (eg if the helium ventilation tube is blocked), a high concentration of helium gas may accumulate in the examination room. This gas forms clouds of cold fog. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: • Immediately remove all persons from the examination room. • Do not turn off air circulation and ventilation in the examination room. • Do not re-enter the examination room until it is confirmed that the oxygen content of the air is at a safe level. Emergency procedures: The user must establish emergency procedures for the following situations: • A medical emergency • A fire • An emergency requiring immediate removal of the magnetic field • The release of helium gas in the examination room Philips magnetic resonance have an emergency stop button in case there is an emergency while moving the table. 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: 03/16/2018 - Date of notification notice for Anvisa: 03/19/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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
    In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as magneto quench) and, at the same time, the helium ventilation tube is prevented. philips learned of a case where this happened on a philips system. in the investigation it was detected that a metal rupturing disc did not perform according to the specifications.
  • Acción
    Field Action Code FCO78100485 triggered under the responsibility of the company Philips Medical Systems Ltda. Field correction


  • Empresa matriz del fabricante (2017)
  • Source