Recall Z-0838-2019 ยท HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Leica Microsystems, Inc.
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
| Date | Sep 25, 2017 |
| Status | Terminated |
| Reason | 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 behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior 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 butt |
| Root cause | Other |
| Action | The firm initiated their field notification by email on 09/25/2017. The firm provided details on the issues and requested the user to take the following actions: "If you notice any of the anomalies as described above before being contacted by a Leica Microsystems representative, please contact your Leica representative for relevant repair of your PROVEO 8. You can continue to use the system pending the intervention of the appropriate Leica Microsystems representative. However, please ensure that a functional check is performed and the system is properly balanced prior to surgery as require |
| Quantity | 142 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.