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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00930-1
Product Name/Description V60 Non Invasive Ventilators (adult mechanical ventilator)

Serial Numbers: 100029455, 100030106, 100030107, 100020111, 100030112, 100030113, 100030115, 100030117, 100030118, 100030120 & 100030121

ARTG Number: 134845
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/09/2012
Responsible Entity Mayo Healthcare Pty Ltd
Reason/Issue A review of manufacturing data found that certain blower motor assemblies in the affected V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. The V60 ventilator will alert users to malfunctioning blowers through audible and visual alarms.
Recall Action Recall for Product Correction
Recall Action Instructions Mayo Healthcare is replacing all affected blower motors.
Contact Information 1300 360 226 - Mayo Healthcare