Events

Recall Or Safety Alert for Patient Monitoring Systems "Expression MRI", model 8652014, with the reusable FlexTemp temperature option, with serial number from US31204918 to US42708744

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
    2015-08-05
  • 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
    Error in the instructions for use of certain Patient Monitoring Systems "Expression MRI", manufactured by Invivo, a division of Philips Medical Systems, relative to the application site of the FlexTemp reusable temperature sensor

Device

Patient Monitoring Systems "Expression MRI", model 8652014, with the reusable FlexTemp temperatur...

Manufacturer

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