Events

Safety Alert for X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 31001/50215/95920/95921/95933/320113.

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

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
    1544
  • Date
    2015-03-23
  • 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 registry holder, there is a serious accident for the patient and operator / technician resulting from the problem: "For the patient: • There is a possibility of disconnection or movement of invasive medical devices. For the Operator / Technician: • There is a possibility of there are compression / crush points in the substructure; and • A possibility of retention between the table and the gantry if the Operator / Technician positions between them to move the patient forward.
  • Reason
    Considering that the maintenance latch is secured and the stem of the maintenance latch is broken, the tabletop can float freely, causing an involuntary horizontal movement.
  • Action
    The company directs the operator to notice a horizontal free floating movement of the table during normal clinical use, immediately stop using the system and contact your Maintenance Engineer. It is important to keep the Safety Warning with the Instructions for Use (IFUs) of the equipment.

Device

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Reg...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA