| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01270-1 |
| Product Name/Description |
Lumenis VersaCut Tissue Morcellator (soft tissue extraction)
All systems manufactured since May 1998
Control Box Model: 0636-470-01
ARTG Number: 176778 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Lumenis is recalling certain models of VersaCut Morcellator devices to perform corrective labelling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook up. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Lumenis Australia is providing improved labels which are to be affixed to the device to reduce the risk of incorrect setup. |
| Contact Information |
03 9862 7822 - Lumenis Australia |