Events

Recall of Arjo-Huntleigh Concerto & Basic Shower Trolleys

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
    20193
  • Event Initiated Date
    2016-05-25
  • 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
    There have been a number of complaints where the bolts under the stretcher have become loose. there has been one minor injury as a result of a patient falling related to these incidents. manufacturer investigated the issue and the conclusion was that he stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher-tilt function may not engage properly, resulting in a patient falling to the floor., the issue relates to a batch of devices manufactured between 7th march 2014 and 20th april 2015.
  • Action
    Product to be modified

Device

Arjo-Huntleigh Concerto & Basic Shower Trolleys
  • Model / Serial
    Model: , Affected: batch of devices manufactured between 7th March 2014 and 20th April 2015.
  • Manufacturer
    ArjoHuntleigh AB

Manufacturer

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