| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01070-1 |
| Product Name/Description |
Nihon Kohden Defibrillator CardioLife, Model Number: TEC 5521 & 5531 (Semi-automated defibrillator)
Serial Numbers: 01590, 00043 & 02082
ARTG Number: 116745 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The defibrillator will cease to work on DC power supply in a specific case (due to electrical damage to a protection circuit) when the battery is fully depleted and no longer able to hold a charge. There is no limitation for the operation of the defibrillator when the AC power is connected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Quarantine and return affected devices to Boab Medical for a software update. |
| Contact Information |
03 9809 4865 - Boab Medical Technologies |