Events

Recall Or Safety Alert for Automatic External Defibrillators (AEDs): • HeartStart FRx, models 861304 and 861305, • HeartStart (HS1) Home and HeartStart (HS1) OnSite; M5066A, M5067A, M5068A models manufactured between September 2002 and February 2013.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/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
    Recall / Safety Alert
  • Date
    2018-04-18
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    • Safety warning related to the possible failure of one of the electrical components of the device (a resistor). • Additional information to that in the user manual, related to the pattern of beeps issued by the defibrillator.

Device

Automatic External Defibrillators (AEDs): • HeartStart FRx, models 861304 and 861305, • HeartStar...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI