Events

Recall of Leica Proveo 8 Ophthalmic Microscope System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Leica Microsystems Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01247-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01247-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Leica Proveo 8 Ophthalmic Microscope System
  • Model / Serial
    Leica Proveo 8 Ophthalmic Microscope SystemSerial Numbers: 190216001, 060516001, 280916001 and 061216001Material Number: 10448808Manufactured prior to July 2017ARTG Number: 137683 (LEICA MICROSYSTEMS PTY LTD - Microscope, surgical)
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd