Events

Recall of Vital Signs LightWand Stylet

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2015-RN-01053-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01053-1
  • 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 safety risk involving a breach in the sterile packaging that may not be recognised prior to use.
  • Action
    The potentially affected customer will be contacted to recall the two affected units they may still have in stock. This action has been closed-out on 30/08/2016.

Device

Vital Signs LightWand Stylet
  • Model / Serial
    Vital Signs LightWand Stylet Catalogue Numbers: 3910 and 3960Lot Numbers: AllARTG Number: 169062
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd