Events

Safety Alert for CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numbers: 31001/32054/32065/32067/52067/52010/52030/52031/52044.

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
    1562
  • Date
    2015-04-02
  • 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 the company during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have the real-time feedback of the needle placement when it is close to the vital structures (large vessel, organ, etc.). .). #### UPDATED ON 07/18/2017, the company sent the completion report of the field action proving the accomplishment of correction, as planned.
  • Reason
    According to record holder information, "during the conduct of the tcc in the ingenuity ct system, the first image was marked as" last capture "instead of the current" last capture "acquired. by pressing the pedal for the first exposure, the images were displayed as the "last shot". subsequent requests did not result in an immediate reconstruction of the image and the first image remained on the screen identified as the "last capture". eventually all images appeared. the problem is caused by incorrect settings for increasing the number of slices in the user set for the tcc protocol resulting from the conversion of the protocol to the exam card during software upgrade from v3.X to v4.0.0 / v4.0.1. in normal tcc mode, the images are reconstructed without delay and the "last capture" is displayed properly with the last reconstructed result. ".
  • Action
    The record holder's recommendations, affected users should check the TCC examination card and correct it if this problem exists. The guidance is to refer to the steps in the Addendum to the safety notice (see annex).

Device

CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numb...

Manufacturer

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