| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00824-3 |
| Product Name/Description |
Halo Flex Energy Generators (Endotherapy electrosurgical unit)
Model Number: 1190A-230A
All serial numbers
ARTG Number: 140684 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Covidien has received reports related to a generator malfunction where the HALOFLEX Energy Generator fails to enter “standby mode” when initially powered-on. The generator became stuck in the self-test mode upon initial power-on, did not enter standby mode, and therefore could not be used for patient care. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The customer letter provides temporary work around instructions. Covidien is developing a software revision, which will be available by the end of August 2012 that will prevent the malfunction from recurring. |
| Contact Information |
1800 350 702 - Technical Services |