Events

Recall of LumaDent Light Battery Charger

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-2016-RN-00746-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00746-1
  • 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 is replacing the battery charger of the lumadent light. this applies to all charger model numbers, except model number sw-084120. model number sw-084120, which is the only correct model for all lumadent batteries bp500 (v3.1, v3.2 and v3.3), is not affected by this recall. the affected battery chargers have not been demonstrated to comply with australian and new zealand electrical safety standards thus may have the potential to overcharge the batteries causing them to overheat and catch fire. there have been no reports of injuries as a result of this issue.
  • Action
    Carl Zeiss are advising users to inspect all battery chargers and quarantine any batteries which are not model number SW-084120. Carl Zeiss will replace any affected stock. This action has been closed-out on 02/03/2017.

Device

LumaDent Light Battery Charger
  • Model / Serial
    LumaDent Light Battery Charger All model numbers affected EXCEPT SW-084120ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd