Events

Safety Alert for X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class III, all equipment

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

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
    1758
  • Date
    2015-11-24
  • 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 letter refers to all of the serial equipment described in the alert.
  • Reason
    According to the registry holder information, the images are not saved in the image directory associated with the 9800 plus system.
  • Action
    The company will send a Letter of Warning and will provide an add-on to the Operator's Manual. Performing other functions (swap, recall, reverse, etc.) while the system is saving an image may result in a failure to save the image in the images directory. When an image is retrieved from the images directory, it may not match the thumbnail. Note that systems with software version 29 and earlier do not show the Save icon, but the sound will work. Press the Help icon to display the software version screen. To access the supplemental text, go to: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library and enter the number 5440340-199-01. More information access Urgent Notice Letter.Code of Action: FMI15129

Device

X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class ...

Manufacturer

GE Healthcare do Brasil