| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01247-1 |
| Product Name/Description |
Leica Proveo 8 Ophthalmic Microscope System
Serial Numbers: 190216001, 060516001, 280916001 and 061216001
Material Number: 10448808
Manufactured prior to July 2017
ARTG Number: 137683 (LEICA MICROSYSTEMS PTY LTD - Microscope, surgical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Through customer complaints, Leica has identified a series of intermittent issues with the Leica Proveo 8 Ophthalmic Microscope System, manufactured prior to July 2017.
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behaviour that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behaviour can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
None of the observed issues were related to an actual or potential risk of patient or user injury. The system remains balanced and allows manual override of all main user functions at all time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Leica Microsystems is providing work around instructions for users to follow as an interim measure. A software and hardware upgrade will be implemented as a permanent correction.
This action has been closed out on 15/04/2020 |
| Contact Information |
02 8870 3500 - Leica Microsystems |