Events

Rappel de LED Single Bay Battery Charger, supplied with LED Headlight System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00760-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00760-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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