Events

Recall of Monitor AC2000 Spring Arm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-2014-RN-00406-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00406-1
  • 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
    Draeger medical australia has been informed of three cases where a welded seam in the spring-loaded arm of the monitor holder broke resulting in the monitor falling. although no injury has been reported, the risk of injury to persons positioned beneath the monitor cannot be excluded.
  • Action
    A Drager service representative will inspect all potentially affected spring-loaded arms. A replacement arm will be provided for all devices determined to be affected.

Device

Monitor AC2000 Spring Arm
  • Model / Serial
    Monitor AC2000 Spring ArmPart Numbers: G19051 and G19262All serial numbers affectedPart Number: G93358All serial numbers until 0111 066 23639 affectedPart Number: G93359All serial numbers until 0111 056 21343 affectedARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd