Events

Safety Alert for Vision Model T-22 Gamma Camera System. Series nº: 1 to 50.

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

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
    389
  • Date
    2002-02-15
  • 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
    The pin of the collimator in the above system may fall and cause the collimator to collapse, which may result in injury. the dealer initiated a correction by letter dated august 27, 2001.
  • Action
    Make sure you received the letter dated August 27, 2001 from GE Medical Systems. You will be contacted by GE's engineering services, who will schedule a visit to reset the collimator pin of the affected product. If you have not yet been contacted by the engineering service, or for more information, contact your local GE Medical Systems representative. 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 more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Vision Model T-22 Gamma Camera System. Series nº: 1 to 50.

Manufacturer

GE Medical System; Hitachi Medical Corp
  • Source
    ANVSANVISA