Events

Recall of OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ClaveGuard 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-00989-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00989-1
  • 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
    Claveguard ols-500 & ols-700 surgical lights manufactured since january 2015 have potential for the locating pin on the light handle to become detached in the event the restraining grub screw works loose.
  • Action
    Dickson & Dickson Healthcare are inspecting all affected systems to ensure the correct installation of the locating pin and perform any corrections required. This action has been closed-out on 18/08/2016.

Device

OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since Januar...
  • Model / Serial
    OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. ARTG Number: 198978
  • Manufacturer
    ClaveGuard Pty Ltd

Manufacturer

ClaveGuard Pty Ltd
  • Source
    DHTGA