| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00318-1 |
| Product Name/Description |
VisuMax Laser
Serial numbers starting with 963599 up to 1157772
ARTG Number: 150527 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Based on complaints, Carl Zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (UPS)-module. It was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the UPS at the rear side of the machine. There were no patient involvement and no adverse consequences associated with these complaints. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.
This action has been closed-out on 23/03/2018. |
| Contact Information |
02 9020 1333 - Carl Zeiss Pty Ltd |