Events

Safety Alert for Name of the manufacturer: Generators Technical name: LEKTRAFUSE HF GENERATOR BIPOLAR Registration number ANVISA: 80136990815 Hazard class: III Affected model: GN200 Affected serial numbers: 2028, 2054, 2060, 2065, 2066, 2071, 2070, 2072, 2074, 2075 , 2077, 2079, 2081, 2083, 2089, 2094, 2149, 2151, 2152, 2153, 2155, 2156, 2172.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; Aesculap AG Tuttlingen (AAG).

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
    2124
  • Date
    2016-12-19
  • 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
    Interruption of the use of said serial numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Reason
    The possibility of the occurrence of a functional disorder in the generators lektrafuse generator af bipolar (gn200) was identified. the mentioned functional disorder is detected by the equipment itself, generating a signaling to the user, unequivocally, in the form of an error message (error f008, code 26) and an acoustic alarm. the generator then enters a safe mode in which the equipment does not operate. to date, the problem in question has not caused any harm to patients.
  • Action
    Field Action Code AC / 06/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for later return to the manufacturer.

Device

Name of the manufacturer: Generators Technical name: LEKTRAFUSE HF GENERATOR BIPOLAR Registration...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG Tuttlingen (AAG)