Events

Recall of Alternating Systems - AtmosAir, Nimbus, Alpha, Active, Response, Logic and Trancell Ranges. Bari Breeze and Autologic 110 & 200; Therakair Visio

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by ArjoHuntleigh AB.

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
    22762
  • Event Initiated Date
    2018-04-03
  • 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: Arjo New Zealand Limited, 34 Vestey Drive, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer will replace a static check valve of foot section of the mattress to a new one to limit a level of noise emitted by the mattress.
  • Action
    Product to be modified

Device

Alternating Systems - AtmosAir, Nimbus, Alpha, Active, Response, Logic and Trancell Ranges. Bari ...
  • Model / Serial
    Model: , Affected: Serial number range from 1600031138 up to 1700046457
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

ArjoHuntleigh AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA