Events

Alerta De Seguridad para Centricity PACS IW, Centricity PACS IW Model with Universal Viewer - Registration 80071260309 - Serial Numbers: Centricity PACS-IW Versions with Universal Viewer: 5.0 to 5.0 Sp 5.1. See attachment: Installed base

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.

¿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
    1693
  • Fecha
    2015-09-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The company informs that the occurrence of the database lock can cause the loss of one or more images in the series. In this case, the physician who will perform the interpretation may not notice the absence of images following the examination, and may therefore suspend therapies, delay treatment or perform interventions based on incomplete information. Until the start date of this field action, no injuries were registered in patients. ### 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
    Ge has identified a security problem with centricity pacs iw. 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. although not frequent, database crashes occur during normal system operations. this field action was already under way at the international level and on august 25, 2015 ge extended the global installed base affected, and this measure included 12 equipment in brazil.
  • Acción
    To correct this problem, you need to update the system software. Until this software update is installed, the following actions are recommended: 1. Use the image counter within the QC (Quality Control) 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: a) If a discrepancy is detected, try to retransmit the exam to the PACS; b) If retransmission fails, a GE Healthcare Technical Assistance representative should be contacted to assist in resolving the affected examination. Urgent cases affected by this problem should be interpreted in the modality. 2. If the DICOM storage confirmation is set up and in use, the images that were impacted by this issue will not send the confirmation notification to the mode. 3. Pay attention to the previous cases, acquired prior to the application of the safety instructions given 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.

Device

Centricity PACS IW, Centricity PACS IW Model with Universal Viewer - Registration 80071260309 - S...

Manufacturer

GE HEALTHCARE