| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01144-1 |
| Product Name/Description |
VisuMax
Catalogue Number: VISMAX
Serial Number: 1173839
ARTG Number: 150527 |
| 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 received information that in certain devices there is an increased probability of failure of the BPC Board. The function of this board is to control an electrically driven mirror which adjusts the laser beam position if necessary. This design allows a position compensation in case the laser beam should drift.
It has been determined that there was a deviation in the soldering process during the manufacture of two batches of the BPC Board which can affect the reliability of the VisuMax beam pointing control subsystem.
The probability of injury is extremely unlikely. Any failure of the BPC Board like error 0x3172 is detected by the monitoring functions of the device either during startup or before start of a treatment. In case of a system error the system test is cancelled before any treatment. If an error occurs, the device goes in a safe mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Complete and return the supplied acknowledgement form. Carl Zeiss service staff will contact users to arrange an appointment for the BPC Board exchange.
This action has been closed out on 18/10/2018 |
| Contact Information |
1300 367 244 - Carl Zeiss |