Recall Z-0838-2019— Leica Microsystems, Inc.

Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2017-09-25, terminated 2020-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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 button is activated..

Recalling firm

Leica Microsystems, Inc.

Classification

Class II

Status

Terminated

Initiated

2017-09-25

Terminated

2020-01-21

Firm location

Buffalo Grove, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.