Events

Recall of LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS (SCHWEIZ) AG.

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
    102904
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • 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 funtionality 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 funtionality. 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.

Device

LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM
  • Model / Serial
    Model Catalog: 10448808 (Lot serial: 011216001); Model Catalog: 10448808 (Lot serial: 041216001); Model Catalog: 10448808 (Lot serial: 230516001)
  • Product Description
    Leica PROVEO 8 Ophthalmic Microscope System
  • Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG

Manufacturer

LEICA MICROSYSTEMS (SCHWEIZ) AG