Events

Safety Alert for ICON P and ICON AP Autoperfusion Workstation Software Version 1.2 designated for use with E.Cam CT with Computerized Emission Systems

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Medical Solutions USA Inc Nuclear Medicine Group.

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
    556
  • Date
    2002-03-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Under certain conditions, the above software may store the data in progress (gated data) instead of the cumulative data used in the last period (nongated). this will occur if the user processes the user to process a simple self perfusion study, and select the save composite option, saving the results of the current page instead of the entire process page. the manufacturer initiated a field correction by letter dated june 26, 2002.
  • Action
    Check that you have received the letter of correction dated June 26, 2002, Siemens self-infusion warning letter. Identify and isolate any affected product in your inventory. The intended use of the cardiac revision application is to evaluate the combined data of stress (gated or nongated) and rest. Saved data is stored in a composite file, which is used to view images within the cardiac review application. If the user chooses to revise only a single current set (gated), or user must choose the "save composite" option from the processing page, not from the results page. If your Auto Perfusion software version is 1.2, and has not been upgraded to version 1.3, always save it on the processing page, not on the results page, when processing a simple dataset. The manufacturer requests that you share this information with all other ICON users on your premises. For more information, contact the Siemens Service Center. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

ICON P and ICON AP Autoperfusion Workstation Software Version 1.2 designated for use with E.Cam C...

Manufacturer

Siemens Medical Solutions USA Inc Nuclear Medicine Group
  • Source
    ANVSANVISA