| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00625-1 |
| Product Name/Description |
V60 Non-invasive Ventilators
Multiple serial numbers affected
ARTG Number: 134845 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
In the rare even a component fails due to a software issue, the following sequence of events may occur:
1) Power Management Board Assembly (PMBA) VMAIN shorts to ground,
2) the ventilator shuts down,
3) the software repeatedly cycles through part of its initialisation sequence and Power On Self Test (POST), the alarm may not sound to indicate that ventilation therapy has ceased. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The V60 ventilator may continue to be used in accordance with its directions for use. A Mayo healthcare representative will be contacting users to schedule the corrective action to upgrade the software. A loan unit will be provided to the users until the corrective action is completed. |
| Contact Information |
1300 360 226 - Mayo Healthcare Customer Service |