Leica PROVEO 8 Ophthalmic Microscope System (2017-09-25)

Starting date:

September 25, 2017

Posting date:

January 29, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65788

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  Reason
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  Affected products

Affected products

Leica PROVEO 8 Ophthalmic Microscope System

Reason

For the Leica Ophthalmic Surgical Microscope Platform PROVEO 8 a series of intermittent issues which negatively influenced customer satisfaction were identified through customer complaints.

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.

Affected products