Events

Recall of LifePoint bPLUS

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Metsis Medikal Ltd Sti.

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
    21574
  • Event Initiated Date
    2017-06-22
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Total Safety Solutions Ltd, 19 Bridgehead Cove, Hobsonville, Auckland 0618
  • Reason
    As a result of the momentary communication interruption caused by the software of automatic external defibrillator devices during the self-test procedure, the device got stuck in stand-by during this process and the bios battery was depleted then the device was locked-up due to processor being subjected to low supply voltage during depletion of bios battery and the warning indicator was stuck in green, not switching to red by full depletion of bios battery. the self-test is performed by the main processor and cannot control the indicator position in the event of possible instantaneous communication and lockup problems.
  • Action
    Software to be upgraded

Device

LifePoint bPLUS
  • Model / Serial
    Model: , Affected: Models: LifePoint Pro, LifePoint bPLUS, LifePoint mPLUS
  • Manufacturer
    Metsis Medikal Ltd Sti

Manufacturer

Metsis Medikal Ltd Sti