Events

Safety Alert for COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (TSX-101A / 8); AQUILION 64 TSX-101A / E and AQUILION 32 TSX-101A / D. SERIAL NUMBERS: HCA0662228; HCA0692325; HCA0712498; HCA0722587; HCA0722590; HCA0732649; HCA0742673; HCA0752696; HCA0782874; HCA07X2929; HCA07X2933; HCA0813065; HCA0823119; HCA0833163; HCA0833172; HCA0863267; HCA0863268 and HCA0792893. Anvisa Registry: 10295030061.

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..

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
    952
  • Date
    2009-02-02
  • 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
    According to Toshiba Medical of Brazil Ltda., When there is a failure in the power supply, the immediate interruption of the x-ray generation occurs, and then the warning message "Abnormal XC Status" is shown to the user. In this way, according to the company, the failure in question does not produce damages to patients and users. If you need to contact the company to handle this case, the contact is as follows: Adriano Bordignom (Technology Manager), Tel. (11) 4134-0063. UTVIG / ANVISA is following up on this case.
  • Reason
    The power supply that controls the x-ray generating unit fails.
  • Action
    The holder of the product registration informed that he has already begun, on 05/01/2009, the process of correcting the problem - by changing the power supplies of the equipment under risk. To the users of the product it is recommended, if the equipment presents the warning message (ABNORMAL XC STATUS), contact the local technical assistance of Toshiba medical do Brasil Ltda (check the address and telephone number in the Manufacturer's description field.

Device

COMPUTERIZED TOMOGRAPH AQUILION. MODELS: MULTI AQUILION (TSX-101A / 4); AQUILION 16 CFX EDITION (...

Manufacturer

TOSHIBA MEDICAL DO BRASIL LTDA.
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    ANVSANVISA