Alerta De Seguridad para SOFTWARE CENTRICITY PACS IW / COM UNIVERSAL VIEWER, Risk Class II, Registry: 80071260309, Centricity PACS-WS in Versions: 3.7.1.1 // 3.7.1.4 // 3.7.2.3 // 3.7.3.1 // 3.7.3.3 // 3.7.3.4 // 3.7.3.5 // 3.7.3.6 // 3.7.3.7 // 3.7.3.8 // 3.7.3.9 // 3.7.3.9 Sp

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; 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
    1563
  • Fecha
    2015-04-21
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    As a consequence of blocking the database, the interpreting physician may not notice the absence of images following the examination, and may therefore provide, suspend therapies, delay treatment or perform interventions based on incomplete information. /// The GEHC informs that this field action does NOT have units imported or distributed in Brazil and, because it is of great relevance, we formally express this negative. There will be no product safety card for the reasons given. ### 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.
  • Causa
    According to information from the registry holder, a database lock may occur during the image acquisition process, affecting the integrity of the acquired images. if the database lock occurs, there is a possibility that one or more images may be missing in the exams. examples of circumstances that may contribute to database crashes include: high number of concurrent users, high number of image acquisition sources, high image count, multiple users modifying studies before receiving all images, and constant requests for access to the database.
  • Acción
    Here are the registration holder's guidelines for the problem: "Until software update is available to correct this problem, the following actions are recommended for the user: 1. Use image counter within the QC process, to alert the user about discrepancies between the number of images transmitted by the mode and the number of images available in the PACS IW viewer. The. If a discrepancy is detected, try retransmitting the exam to the PACS. B. If retransmission fails, a GE Healthcare Technical Assistance representative should be contacted to provide assistance in resolving the affected examination. Urgent cases affected by this problem should be interpreted in the modality. 2. If DICOM storage confirmation is configured and in use, images that are impacted by this issue will not send confirmation notification to the mode. 3. Pay attention to the previous cases, acquired prior to the application of the safety instructions provided in this release, as these cases may have been affected by this security problem. For questions about history data, contact GE Technical Assistance for assistance in identifying any affected images. "

Manufacturer