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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00760-1
Product Name/Description LED Single Bay Battery Charger, supplied with LED Headlight System

Catalogue 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, IE131010

ARTG number: 194313 (Battery Charger) /188571 (Headlight System)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/07/2014
Responsible Entity Integra Neurosciences Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions Customers are asked to review their Integra LED battery charger inventory. Integra will issue replacements, if customers have the affected battery chargers.
Contact Information 1300 550 599 - Integra Customer Service