Events

Safety Alert for BrightView

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine 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
    I1411-491
  • Event Number
    2008DM-0001422
  • Date
    2014-11-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=191
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it is possible that unscheduled detector and gantry movements may occur, caused by conflicts in the software when performing specific test sequences, leading to possible adverse events on the patients.

Device

BrightView
  • Model / Serial
    Brightview with 3/8 "glass, Brightview with 3/8" glass and cephalic flow detector, Brightview X with 3/8 "glass and || Brightview XCT, with software versions 1.2.3 / 2.5.3
  • Product Description
    Clinical diagnosis system by nuclear medicine designed to produce diagnostic images from the detection of radiation that is previously supplied to the patient through a radioactive drug or tracer radioactive with a drug known metabolic pathway.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine Inc
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NIDFSINVIMA