Events

Recall of Welch Allyn Schiller AG 1500 Monitor (multi parameter patient monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Welch Allyn Australia Pty Limited.

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-01177-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01177-1
  • 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
    Welch allyn has advised that they inadvertently shipped the incorrect user manual and quick reference guide for the welch allyn 1500 monitor, which did not include some additional functions available in the device, which include cardiac output, hemodynamin and integrated pulmonary index (ipi).
  • Action
    Updated Instructions for Use (IFU) will be issued.

Device

Welch Allyn Schiller AG 1500 Monitor (multi parameter patient monitor)

Manufacturer

Welch Allyn Australia Pty Limited