| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00924-1 |
| Product Name/Description |
Test Tube Heater - Power Supply Unit
Test Tube Heater Part Number: K-FTH-1012
Power Supply Unit Part Number: K-APS-300
ARTG Number: 140546 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
The power supply of the devices are being replaced because recent testing of the combination of the test tube heater and power supply was found to exceed the prescribed electromagnetic compatibility (EMC) limits for radiated emissions.
As the level of excess emissions are only slightly over the prescribed limits, and because the exposure to the radio frequency (RF) fields is far below internationally accepted safety levels, it is unlikely that there are any health risks to the user or patient posed by the non-conforming combination of the test tube heater (K-FTH-1012) and power supply (K-APS-300). It is also unlikely for the power supply to affect the operation of the test tube heater as this device is designed to have RF immunity greater than the radiation emitted by the power supply. |
| Recall Action |
Recall |
| Recall Action Instructions |
William A. Cook Australia will provide an alternative power supply unit. End users are requested to discontinue use and destroy the affected units. This action has been closed-out on 01/03/2016. |
| Contact Information |
07 3841 1188 - William A Cook Australia |