Leica Microsystems, Inc. recalls PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification…

Recall date

September 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0838-2019

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.