Events

Recall Or Safety Alert for Angiographic apparatus with accessories and consumables Innova 2121 IQ (serial number 589404BU3)

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by GE Medical Systems SCS, FRANCE.

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
  • Event Number
    ИМ-7.97382
  • Date
    2014-03-03
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    The manufacturer has determined that the innova system may not boot after turning on the power or after rebooting the system. also, the system can arbitrarily shut down during research, which can lead to a complete loss of interventional visualization in real time. the loss of visualization capability during fluorography can cause significant harm to the patient, if coronary intervention occurs during the "sensitive phase".

Device

Angiographic apparatus with accessories and consumables Innova 2121 IQ (serial number 589404BU3)

Manufacturer

GE Medical Systems SCS, FRANCE