| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01150-1 |
| Product Name/Description |
Slit Lamp
Model Number: SL 220
Serial Numbers: 970712XXXX and 970714XXXX
ARTG Number: 94353 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Based on post market surveillance activities, Carl Zeiss has determined that in certain devices there is an increased probability of failure of the power supply ON/OFF switch, and surface corrosion of the mirror which changes the direction of the light projection.
There is no potential health hazard and the probability of injury is extremely unlikely. In a worst case scenario, a burning smell may result from a thermal event at the power supply ON/OFF switch. Issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. The slit projection may be slightly darker and more diffused. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.
This action has been closed out on 18/09/2018 |
| Contact Information |
1300 367 244 - Carl Zeiss |