Events

Recall of Integra LED Headlight system, single bay battery charger

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Integra Burlington MA Inc.

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
    16944
  • Event Initiated Date
    2014-07-07
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Reason
    The manufacturer has identified 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. there have been no reports of an injury or other adverse patient consequences associated with the complaints.
  • Action
    Product to be exchanged

Device

Integra LED Headlight system, single bay battery charger
  • Model / Serial
    Model: Model:s: 90523 (battery charger), 90520AU (LED Headlight system), Affected: Selected lot numbers
  • Manufacturer
    Integra Burlington MA Inc

Manufacturer

Integra Burlington MA Inc