Events

Safety Alert for Ultrasound Diagnostic System. Models at risk: SSA-660A, SSA-790A, SSA-680A, SSA-780A. Anvisa Registry n ° 10295030071.

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

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
    1474
  • Date
    2014-12-02
  • 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
    Under certain conditions, the surface temperature of the transducers may increase when used in 2D + PW mode or 2D + CDI (Power, ADF) + PW mode and depending on the transducer the time for this temperature increase varies as follows: - PST-65AT (approximately 20 seconds); PVT-745BTF / H, PVT-674BT (approximately 3 minutes); PVT-661VT (about 5 minutes); - Other transducers (15 minutes or more). #### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    Under certain conditions, the surface temperature of the transducers that make up the equipment may increase.
  • Action
    Field correction. The company will install software to correct the problem.

Device

Ultrasound Diagnostic System. Models at risk: SSA-660A, SSA-790A, SSA-680A, SSA-780A. Anvisa Regi...

Manufacturer

Toshiba Medical do Brasil Ltda.; Toshiba Medical Systems Corporation
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    ANVSANVISA