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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01059-1
Product Name/Description eVent Medical Inspiration LS & i Series Ventilator Systems

Serial Number: 2009W030040

ARTG Number: 133128
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 28/10/2015
Responsible Entity The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia
Reason/Issue Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. This failure could result in death or serious injury to a patient.
Recall Action Recall for Product Correction
Recall Action Instructions Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016.
Contact Information 03 9330 4940 - Taleb Medical