Leica Proveo 8 Ophthalmic Microscope System 의 리콜

Recall

RC-2017-RN-01247-1

Class II

2017-10-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01247-1

Through customer complaints, leica has identified a series of intermittent issues with the leica proveo 8 ophthalmic microscope system, manufactured prior to july 2017.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 hor recording unit. additionally, an anomaly in the device software may also lead to the unexpected behaviour that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. this behaviour 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.None of the observed issues were related to an actual or potential risk of patient or user injury. the system remains balanced and allows manual override of all main user functions at all time.

Leica Microsystems is providing work around instructions for users to follow as an interim measure. A software and hardware upgrade will be implemented as a permanent correction.