Events

Safety Alert for Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 80071260269, serial number of the affected unit: XV650620BU8.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil; GE MEDICAL SYSTEM S.C.S..

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
    1604
  • Date
    2015-06-07
  • 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 the company, if the Gantry Motion Control Board (MCB) fails, limiting the movement of the fluoroscope may interfere, complicate or prolong any interventional procedure that is dependent on multiple fields of view , affecting the diagnostic and therapeutic accuracy of the image. The ability to perform imaging and diagnostics can also be impaired.
  • Reason
    Safety problem related to the loss of the ability to move the arm gantry in c (c-arm) in the system of interventional imaging of fluoroscopy. loss of gantry movement capacity is caused by a failure in the gantry motion control board (mcb). after system reboot, x-rays and manual movements of the gantry and table shafts will be available.
  • Action
    The company will make a field correction of the affected equipment. The user can continue to use the system, avoiding abrupt changes of direction with the movements of the gantry and preventing potential collisions with other equipment. If failure occurs during an interventional examination / procedure, the user should ensure that he / she has the procedures in place to handle patients in the event of loss of gantry movement as described on the labeling of their product.

Device

Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 8...

Manufacturer

GE Healthcare do Brasil; GE MEDICAL SYSTEM S.C.S.