Events

Recall Or Safety Alert for Monitors of physiological constants of the Infinity® Family, Delta Models, Delta XL and Kappa, with software version VF10.0, used in combination with the gas measurement modules Dräger Scio, Scio Four, Scio Four Oxi Plus, Scio Four Oxi and Scio F

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 Dräger Medical System 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
    Recall / Safety Alert
  • Date
    2017-04-11
  • 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 certain alarms of high and medium priority are not generated in the Monitors of the Infinity® Family, Delta, Delta XL and Kappa models, with software version VF10.0, manufactured by Dräger Medical System Inc., USA, when Used in combination with Dräger Scio gas measurement modules.

Device

Monitors of physiological constants of the Infinity® Family, Delta Models, Delta XL and Kappa, wi...

Manufacturer

Dräger Medical System Inc.