Events

Safety Alert for Body Composition Analyzer INBODY

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A..

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
    R1711-528
  • Event Number
    2013DM-0009968 ; 2013DM-0010753
  • Date
    2017-11-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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
    Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed without complying with the full requirements demanded by the technical and legal provisions that regulate it, for which the product recall was requested in a preventive manner, as it is considered a fraudulent product.

Device

Body Composition Analyzer INBODY
  • Model / Serial
  • Product Description
    Body composition analyzer INBODY performs an analysis by bioelectrical impedance (BIA) in a segmental, multifrequency and octopolar way, emits results regarding: 1-diagnosis of obesity 2-edema 3- nutritional evaluation 4-evaluation of weight 5-body balance 6- body strength 7-weight control 8- BMR 9- health score Human body movement analysis for orthopedics and rehabilitation, prostheses and orthoses, sports medicine, respiratory therapy, ergonomics and occupational health.
  • Manufacturer
    Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A.

Manufacturer

Biospace Co. Ltd. || Inbody Co., Ltd || BTS S.P.A.
  • Source
    NIDFSINVIMA