Events

Safety Alert for Geratherm heating system for patients, Unique Temp model, registration 80200260007, risk class III. Number of series affected: 0601244 - lot 171202803; and L06021202 - code 80001240301.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Geratherm Medical do Brasil Ltda.; Geratherm Medical AG..

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
    1618
  • Date
    2015-06-18
  • 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
    Use of the product may result in burns to the user.
  • Reason
    Warming up the expected of the blanket for body temperature control.
  • Action
    Customers are advised not to use the product in case of overheating.

Device

Geratherm heating system for patients, Unique Temp model, registration 80200260007, risk class II...

Manufacturer

Geratherm Medical do Brasil Ltda.; Geratherm Medical AG.