Events

Field Safety Notices about Volcano 55, sSi, CORE and CORE Mobile

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Philips.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-05-06
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Volcano is launching a voluntary remedial action on its own, because one problem has arisen with the v3.2.X, v3.3 and v3.4 software versions running on 55 / ssi / core / core mobile systems ("affected systems") . the withdrawal covers only the affected systems. volcano was aware of the incompatibility between the affected systems and the hospital network scan. in special circumstances b0 the affected system encounters unexpected data from the i2 hospital network for which the system will have to be restarted manually. this condition can occur at any time, even in the middle procedure on the patient.

Device

Volcano 55, sSi, CORE and CORE Mobile
  • Model / Serial
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS