Events

Recall of NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00247-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00247-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Two laptops returned from medtronic japan distribution centre alleged a power supply issue. the defective power supply could impact the performance of the gui by introducing latency (delay) in its performance. however, once the units are turned on while connected to their respective power supplies (dell 90 watt ac adapters), the users would be warned by the "ac alert message" that is shown on the screen during the boot up process. this issue is unlikely to present a hazard to either the patient or the user. there have been no complaints or adverse events reported for this issue from the field.
  • Action
    Medtronic will replace the affected power supply units with unaffected stock. This action has been closed-out on 27/01/2017.

Device

NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular mon...
  • Model / Serial
    NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)Lot / Batch numbers: X06016674, X06016675, X06018893, X06026959,X06026960, X06026961, X06026962, X06026963,X06040001, X06040002, X06042171, X06042172,ARTG number: 169810
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty 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
    DHTGA