Events

Safety Alert for defibrillator Zoll series M

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zoll Medical Corporation.

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
    I1507-327
  • Event Number
    2009EBC-0003880
  • Date
    2015-07-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • 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 states that the previous electrodes could be labeled with the reference number and date of incorrect expiration, the correct expiration date is april 18, 2017, leading to potentially confusions with the devices.

Device

defibrillator Zoll series M
  • Model / Serial
    8900-3000-01 and 8900-3001-01, lot 1615, referring to patient electrodes manufactured in April 2015.
  • Product Description
    This product combines a defibrillator with advanced capabilities of ECG monitors and non-invasive transcutaneous rhythm (NTP) with communication, data printing and recording capabilities, designed to support cardiopulmonary resuscitation.
  • Manufacturer
    Zoll Medical Corporation

Manufacturer

Zoll Medical Corporation