Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE HEALTHCARE.

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
    1693
  • Date
    2015-09-29
  • 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
    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.
  • Reason
    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.
  • Action
    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