| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00572-1 |
| Product Name/Description |
Vadi Filter Heater power switches
Part number: VD-800-VH330
ARTG 322674
(Device Technologies Australia Pty Ltd - Filter, humidifier, heat/moisture exchange) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Vadi Medical Technology Co. have determined that, due to a manufacturing process, there is potential for the plastic cover of the power switch to crack.
If the plastic cover of the power switch cracks, the following problems may occur:
• A faulty switch can prevent the device from operating properly.
• It may fail to be turned on and delay treatment.
• It may fail to allow the device to be turned off when the temperature is deemed too high.
• A spark might cause burn injury.
The previous communication for this problem was issued in January 2023, titled Product Defect Alert TGA Ref: RC- 2022-RN-01404-1. |
| Recall Action |
Recall |
| Recall Action Instructions |
Identify the quantity and serial number(s) of affected stock that you have and fill out the customer reply form supplied with the customer letter.
Attach a photograph showing the faulty switch and serial number of the affected unit(s), and Device Technologies will contact you to arrange a credit.
Distribute this notice to all users of the affected devices. |
| Contact Information |
0427 016 075 - Nicholas Arnold - Product Manager |