| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00930-1 |
| Product Name/Description |
Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. (Light Source for endoscopic procedures)
Catalogue Numbers:
BLS-1000 kit (battery & charger) - 07-3053-AUS
Charger - 07-3058-AUS
Lithium-Ion Batteries - 07-3059
ARTG Number: 137738 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Vision-Sciences received a limited number of reports relating to over-heating and possible burning of the lithium-ion batteries being charged with the Vision-Sciences Battery Charger. As a precautionary measure Vision-Science has initiated a recall action, to retrieve all battery charges and dispose of the rechargeable batteries. Endoscopes or light sources are not affected by this recall. AshMed Pty Ltd is the current sponsor and distributor for the Vision Sciences Inc range of endoscopes and accessories in Australia and New Zealand. |
| Recall Action |
Recall |
| Recall Action Instructions |
AshMed Pty Ltd is requesting their customer to immediately remove Vanson V-95 Battery Charger from use and mail the affected charger/device to AshMed Pty Ltd, and dispose of rechargeable batteries as per the local regulations. AshMed Pty Ltd and Vision Sciences Inc will supply replacement disposable batteries for the BLS-1000 unit until a permanent replacement that will meet appropriate standards of quality and safety is found. |
| Contact Information |
1300 680 898 - AshMed Pty Ltd |