| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00094-1 |
| Product Name/Description |
Valleylab FT10 energy platform
Item Code: VLFT10GEN
ARTG: 178604
(Medtronic Australasia Pty Ltd - Electrosurgical system generator, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has been made aware that the power supply for the device fails when exposed to voltage spikes. Medtronic has developed a new power supply that will withstand the voltage irregularities experienced in the Australian market. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic will contact customers to arrange a service technician to install a new power supply in affected devices. In the interim, users should ensure the device is attached to a wall outlet and the wall switch is in the 'ON' position at all times until the unit has been upgraded.
This action has been closed out on 11/10/2019 |
| Contact Information |
1800 336 693 - Medtronic Customer Service Support |