Alerta De Seguridad para Trade name: SPECT Brightview System. Technical Name: Cinch Recorder (Gamma Camera). ANVISA registration number: 10216710177. Risk class: II. Model Affected: N / A. Serial numbers affected: 4000009, 4000184, 4000305, 4000303, 4000324, 4000411, 4000516, 4000554, 4000566, 4000576, 4000614, 4000612, 4000627, 4000669, 4000681, 6000109, 6000126, 6000276

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 (Cleveland), Inc..

¿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
  • 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
    It is recommended that the technologist remain free of moving parts during the exchange of collimators, in addition to the interaction required to engage / disengage collimator carriages with the system. It is recommended that the technologist keep his or her feet out of the collimator carts while it fits / detaches from the camera. It is also recommended that the technologist observe the system during the exchange of collimator and press an E-stop button if something unexpected / not as described in the IFU. Follow the Notice provided in the Instructions for Use (IFU) for BrightView as referenced in 459800422482 Rev B, Section 2, p. 25-26 and 110 which states: "WARNING During the exchange of the collimator, the detector latches enclose the collimator; the system moves the detector away from the collimator stand and pauses so that you can examine the detector and the collimator to make sure that the operation is in progress normally. If you want to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) 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: 12/19/2017 - Date of notification notice to Anvisa: 12/29/2017 The company holding the registration of 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
    Philips has identified a problem during the exchange of collimators that may result in the collimator falling from the detector head or the collimator cart.
  • Acción
    Field Action FSN Code CLE17-076 triggered under the responsibility of Philips Medical Systems Ltda. It will update preventive maintenance procedures to verify and correct any misalignment and / or loose parts associated with collimator switching.


  • Empresa matriz del fabricante (2017)
  • Source