Events

Recall Or Safety Alert for Integris Allura Xper FD10 cardiovascular intervention system, model 722003, configuration ES660042926, with a Velara generator with identification code 12 NC 9890-000-70125

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 BV.

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
    2017-01-12
  • 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
    Safety problem in the Velara generator of a limited number of Integris Allura Xper cardiovascular intervention systems, manufactured by Philips Medical Systems BV, Holland, which could cause system blockage.

Device

Integris Allura Xper FD10 cardiovascular intervention system, model 722003, configuration ES66004...

Manufacturer

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