| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00041-1 |
| Product Name/Description |
Vadi Heater
Part Number: VH220
ARTG Number: 212166
(AHC Solutions Pty Ltd - Filter, ventilator) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
AHS Solutions P/L has been made aware of an issue regarding overheating of Vadi Heater VH220 causing shrinkage of the filter due to dysfunction of the cut-off switch.
The root cause analysis found that the dysfunction of the switch is due to the distance from the tape to glue the switch to the heating scroll not being attached closely enough. As a result, there is a gap between switch and Aluminium heating scroll, which, after a long term use, can damage the switch. The damaged switch will therefore be unable to control the temperature, causing overheating which deforms the filter. |
| Recall Action |
Recall |
| Recall Action Instructions |
AHC Solutions is advising users to dispose of VH220 heaters that are currently in use. Customers will be provided with replacement heaters.
This action has been closed out on 15/02/2019 |
| Contact Information |
02 9980 8823 - AHC Solutions |