Recall of Alaris PC Unit (General purpose infusion pump)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-00710-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-07-12
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    The manufacturer has identified a potential risk associated with a component on the pc unit power supply board which is causing an error code (120, 4630) "system error" or "missing battery error" at start up or prevent programming changes if the problem occurs during use.
  • Action
    If error observed remove PC unit from use. PC Unit boards replaced.

Device

Manufacturer