Events

Safety Alert for Ultrasound Diagnostic System Technical Name: Ultrasound Device ANVISA Registration Number: 10295030071 Hazard Class: II Affected Model: TUS-X100, TUS-X100S, TUS-X200 and TUS-X200S

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

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
    2186
  • Date
    2016-09-20
  • 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
    Software update must be performed for fault correction.
  • Reason
    It has been found that for the tus-x100, tus-x100s, tus-x200 and tus-x200s versions 1.0 to 3.0, the acoustic lens surface of the transducer may become hot. this is due to the occurrence of a software error when the transducer is disconnected and reconnected, changed, or another transducer is selected.
  • Action
    Field Action Code IMF-MUB03 triggered under the responsibility of the company Toshiba Medical do Brasil Ltda. Company will make correction in the field.

Device

Ultrasound Diagnostic System Technical Name: Ultrasound Device ANVISA Registration Number: 102950...

Manufacturer

Toshba Medical do Brasil; Toshiba Medical Systems Corporarion
  • Source
    ANVSANVISA