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

Recalled February 27, 2019 · FDA recall Z-0838-2019 · Leica Microsystems

Hazard
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. · FDA Class II
Units
142 units
Sold at
Worldwide

Description

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.

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.
Manufacturer(s)
Leica Microsystems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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