Events

Recall of LED Single Bay Battery Charger, supplied with LED Headlight System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-00760-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00760-1
  • 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
    Integra neurosciences has been notified by the manufacturer that they have identified through an investigation of complaints that some lot numbers of the integra led single bay battery charger may prematurely fail and will not charge the integra led battery as intended. also, there were isolated complaints that sparks were observed due to pc board components not meeting their specification requirements.
  • Action
    Customers are asked to review their Integra LED battery charger inventory. Integra will issue replacements, if customers have the affected battery chargers.

Device

LED Single Bay Battery Charger, supplied with LED Headlight System
  • Model / Serial
    LED Single Bay Battery Charger, supplied with LED Headlight SystemCatalogue numbers: 90523 (battery charger); 90520AU (LED Headlight system)Lot numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010ARTG number: 194313 (Battery Charger) /188571 (Headlight System)
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd