Events

Recall Or Safety Alert for "AutoSPECT Pro" reconstruction application of the Extended Brilliance WorkSpace NM workstations, software version 2.0.0

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 (Cleveland) 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
    2016-04-08
  • 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 of a diagnostic error with the AutoSPECT Pro application on the Extended Brilliance WorkSpace NM workstation, software version 2.0.0, manufactured by Philips Medical Systems (Cleveland) Inc., USA, when using gamma cameras that allow acquisition modes other than the relative 90 and 180 degrees

Device

"AutoSPECT Pro" reconstruction application of the Extended Brilliance WorkSpace NM workstations, ...

Manufacturer

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