Events

Safety Alert for Ingenuity CT / Brilliance CT / Ingenuity Flex / MX8000 Dual v. EXP. Model: Brilliance CT (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP - Registro Anvisa nº 10216710191, 10216710209 e 10216710142

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems.

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
    1406
  • Date
    2014-04-14
  • 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
    There is a risk of serious injury to the patient and Technician / Operator as a result of table movement. For the patient: • There is a possibility of withdrawal or movement of invasive medical devices, such as IV, tracheostomy and tracheostomy drapes. To the Technician / Operator: • There is a possibility of crushing point in the subframe; and • A possibility of locking between the table and the Gantry if the Technician / Operator remains between them to move the patient ahead
  • Reason
    If the coupling is not properly locked during operation of the device, the table frame moves freely, causing accidental horizontal displacement. it results in serious damage with probability of occurrence not expected. risk analysis: acceptable.
  • Action
    Sending User Safety Warning

Device

Ingenuity CT / Brilliance CT / Ingenuity Flex / MX8000 Dual v. EXP. Model: Brilliance CT (6, 10, ...

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA