| 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 |
|
| 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 |