| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00158-1 |
| Product Name/Description |
Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination
Material Numbers: 10448480 and 10448662
Serial Numbers: OH5-31311, OH5-51813, OH5-53113, OH5-55313, OH5-53413, OH5-57013, OH5-56613, OH4-107114 and OH5-67314
ARTG Number: 137683 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the manufacturer's attention that an electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could lead to an unforeseen behaviour:
An electronic component in one of the two illumination units can potentially overheat, resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Leica is advising users that the microscope will continue to function if the failure occurs, and is providing users with instructions on how to switch the microscope to the back-up illumination unit. Leica will be providing a replacement power supply cable to prevent the issue from occurring. This action has been closed-out on 25/01/2017. |
| Contact Information |
1800 625 286 - Leica Microsystems |