Events

Alerta De Seguridad para Centricity PACS IW, Centricity PACS IW models with Universal Viewer and Centricity Universal Viewer; registration 80071260309, risk class II, products under risk: Centricity PACS-IW with Universal Viewer versions 5.0 SP2 and higher; Centricity Universal Viewer versions 6.0 and higher.

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
    1717
  • Fecha
    2015-10-15
  • 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
    According to manufacturer if references of known size are not present in the image and manual calibration is not possible, this may lead to an exaggerated estimation of the measurements of distances in the images. Incorrect measurement of distances can lead to misinterpretation of images, which are used as the sole or main basis for planning or retaining an intervention. However, some measurements may be outside the physiological range or independently verified, which will cause the measurement discrepancy to be detectable. ### 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 record holder information, a security issue has been identified with either the centricity pacs and centricity enterprise archive products or the retrieval of dicom file images from a neutral vendor, which may display inaccurate measurements of extended views acquired from digital x-ray systems . this failure occurs because certain scanner magnification factors are not considered by universal viewer. more specifically, distance measurements may not be accurately calculated when viewing projected radiographs and fluoroscopy images, which contain imager pixel spacing (0018, 1164) and magnification factor ] (0018, 1114) in the dicom header, but does not contain pixel spacing values ​​(0028, 0030). full-size film / paper printing of images produced by modes is also impacted by this security problem.
  • Acción
    Software update. The company's recommendations are that for all projection X-rays, users must perform the necessary measurements on the standard contact images and not rely on the measurements made in the magnified view unless the measurements of each X-ray equipment have been checked independently or manually calibrated using a radiopaque reference of a known size. In addition, users should pay attention to cases acquired prior to the application of these safety instructions in the urgent security warning (attached to this form), as these cases may be affected by the security problem.

Device

Centricity PACS IW, Centricity PACS IW models with Universal Viewer and Centricity Universal View...

Manufacturer

GE Healthcare do Brasil; GE HEALTHCARE