Events

Recall of Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Arjo Australia 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-2018-RN-00123-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00123-1
  • 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
    Arjo has received a limited number of complaints where it was noted there was a disconnection of the spreader bar from the quick connect scale.This occurence may result in users falling whilst the device is in use.
  • Action
    Arjo will be in contact with affected users to arrange for devices to be upgraded

Device

Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.
  • Model / Serial
    Arjo Quick Connect Scale used with Maxi Sky 2Manufactured between June 2016 and November 2017.Part Number: 700-19490Serial Numbers range 300142013 - 300219867Part Number: 700-19485 Serial Numbers range 300146551 - 300220716ARTG Number: 276363(Arjo Australia - Scale, patient, sling)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA