Events

Recall of ML 301 Examination Lamp

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical & Optical Instruments 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-2013-RN-00217-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00217-1
  • 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 are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. the manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. if the joint breaks, the spring arm falls suddenly and without hindrance. in such a case there is a high risk of injury to the patient and other persons in the immediate vicinity.
  • Action
    End users are requested to inspect all units to determine if the swing arm has a plastic joint. If the joint is plastic the spring arm must not be used. A replacement spring arm will be provided for all affected units.

Device

ML 301 Examination Lamp

Manufacturer

Medical & Optical Instruments Australia Pty Ltd