Alerta De Seguridad para Trade name: Centricity Pacs IW. Technical Name: Software. ANVISA registration number: 80071260309. Risk class: II. Affected Model: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer. Serial Number Affected: Centricity Pacs IW With Universal Viewer | Centricity Universal Viewer (80071260309)

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; GE Healthcare.

¿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
    Until the update is available to correct this problem, the following actions are recommended. 1. Use the image counting within the QC process to alert the user to a discrepancy in the number of images transmitted from the mode regarding the number of available images. The. If a discrepancy is identified, try retransmitting the exam to the PACS. B. If retransmission is unsuccessful, a GE Healthcare Maintenance representative should be contacted to assist in resolving the impacted examination. Urgent cases impacted by this problem should be interpreted in the modality. 2. If the DICOM storage commitment is configured and in use, no commit notification will be sent to the imaging mode that has been affected by this problem. 3. Attention should be paid to the previous cases, which were acquired prior to the application of the safety instructions given in this communication, as they may be affected by the safety problem. For historical data queries, contact GE Maintenance for assistance in identifying any affected images. 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: 09/25/2017 - Date of notification notice to Anvisa: 02/20/2018 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
    A database management error may occur during the image acquisition process, which can affect the integrity of the acquired images. there is a possibility that one or more "image series" (that is, all images within a set of images) may be missing in an examination without the user warning display. although this is rare, this can occur with imaging studies that have a very small number of images per series. for example. chest examination by cr with 1 image per series. there were no injuries reported as a result of this problem.
  • Acción
    Field Action IMF Code 85442 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Will make field correction