Events

Recall of LumaDent Light Battery Packs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carl Zeiss 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-2014-RN-01248-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01248-1
  • 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
    Carl zeiss pty ltd, following advice from lumadent inc (manufacturer of the lumadent light) is replacing the battery packs of the lumadent light for battery packs with a serial number starting with bp0114. the affected battery packs may have a fault that has the potential to cause the batteries to overheat and catch fire.
  • Action
    Customers are asked to inspect their battery packs and quarantine all affected units for recovery and replacement with unaffected stock. This action has been closed-out on 07/07/2016.

Device

LumaDent Light Battery Packs
  • Model / Serial
    LumaDent Light Battery PacksBBatch numbers starting with BP0114ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd