Events

Safety Alert for Cardiocall event recorder

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Spacelabs Medical 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
    I1511-519
  • Event Number
    2008DM-0003080 sonido doble, seguido de un timbre continuo que solo se
  • Date
    2015-11-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 has identified that the equipment can emit undetiene when removing the battery, leading to possible delays in the care of patients.

Device

Cardiocall event recorder
  • Model / Serial
    Models VS20, VS20x4, ST80 and ST80x4 and PCBA part number 670-1670-00, dispatched between December 23 || of 2014 and August 19, 2015
  • Product Description
    This equipment has been designed and provided specifically for the monitoring of electrocardiograms activated by the patient. Indicated to record the electrocardiogram when a patient experiences intermittent transient symptoms such as dizziness, palpitations or shortness of breath, and this is able to activate the recorder in these sessions. The electrocardiogram is stored in memory.
  • Manufacturer
    Spacelabs Medical Inc.

Manufacturer

Spacelabs Medical Inc.