Events

Safety Alert for Software, CENTRICITY RIS / PACS - IW, registration 80071260105; class I, versions 3.5.0 to 3.7.3.9 SP2, 3.7.3 SPA10 and 4.0.1.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; DYNAMIC IMAGING LLC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1710
  • Date
    2015-10-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    According to available data, the likelihood of loss of random images causing serious damage is classified as "Rare". In the reconstructed planes, the missing cuts will be visualized as a line of anatomical discontinuity along the images. In this way, the consecutive loss of images can be detection. Failure to detect missing images may result in a false negative diagnosis if the radiologist does not notice the lack of images.
  • Reason
    A problem that can affect the integrity of the exams. when the "maproute" system parameter is set to a value greater than 1, not all images in an exam may be processed, resulting in a potential loss of one or more of the exam images.
  • Action
    Software update. The registry holder will remotely inspect the affected systems to verify the value of the "MapRoute" parameter. If the value found is greater than the recommended setting of 1, it will reset the system parameter to value 1. The user should not make any changes to the value of this parameter until an update is available to correct this problem, the following actions: 1. Use the image counter within the QC (Quality Control) process to alert the user to discrepancies between the number of images transmitted by the mode and the number of images available in PACS IW viewer.a. 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 problem will not send confirmation notification to the mode.Code of Action: FMI85410

Device

Software, CENTRICITY RIS / PACS - IW, registration 80071260105; class I, versions 3.5.0 to 3.7.3....

Manufacturer

GE Healthcare do Brasil; DYNAMIC IMAGING LLC