Events

Recall of Spacelabs Healthcare Integrated Module Housing (Used for accommodating additional modules to the patient monitor whenever needed)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-2012-RN-00877-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00877-1
  • 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
    There is a potential failure of the integrated module housing; causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
  • Action
    Medtel is providing work around instructions to users to mitigate the issue until a permanent fix can be installed.

Device

Spacelabs Healthcare Integrated Module Housing (Used for accommodating additional modules to the ...
  • Model / Serial
    Spacelabs Healthcare Integrated Module Housing (Used for accommodating additional modules to the patient monitor whenever needed)Model Number: 91493ARTG Number: 128789
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA