Events

Recall Or Safety Alert for Phototherapy systems with LED NeoBLUE® Blanket

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 Natus 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
    Recall / Safety Alert
  • Date
    2016-12-16
  • 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
    New version of the technical bulletin on the operation of the NeoBLUE® Blanket LED Phototherapy Systems, manufactured by Natus Medical Inc., USA, including the reliability update to prevent the fiber optic light beam from deteriorating prematurely.

Device

Phototherapy systems with LED NeoBLUE® Blanket

Manufacturer

Natus Medical Inc