Recall – Optical system displays unexpected behavior under certain conditions

Company: Leica Microsystems, Inc.
Date of Enforcement Report: 2/27/2019
Class II:

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.

Recall Number: Z-0838-2019

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/MANUFACTURER

Leica Microsystems, Inc. on 9/25/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
142 units

DISTRIBUTION

Worldwide

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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