Events

Field Safety Notices about Warning Lamp Connectors & Chiller associated with PoleStar® N20 IMRI Navigation System and PoleStar N30 Surgical MRI System

According to Danish Medicines Agency, this field safety notices involved a device in Denmark that was produced by Medtronic Navigation Israel, Ltd..

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.

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Device

Warning Lamp Connectors & Chiller associated with PoleStar® N20 IMRI Navigation System and PoleSt...

Manufacturer

Medtronic Navigation Israel, Ltd.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DMA