Events

Recall Or Safety Alert for Defibrillators / Monitors "HeartStart MRx" with software version F.03.06, and T.00.05 or lower, part number 861288, model number M3535A, and part number 861289, model number M3536A

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 Philips Medical Systems.

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
    2015-11-25
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • 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
    Possibility that in certain "HeartStart MRx" Defibrillators / Monitors, manufactured by Philips Medical Systems, United States, the automatic test stops, and the "Ready to Use" indicator shows an anomaly not described in the instructions for use.

Device

Defibrillators / Monitors "HeartStart MRx" with software version F.03.06, and T.00.05 or lower, p...

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AEMPSVFOI