Health product recall

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

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

Leica PROVEO 8 Ophthalmic Microscope System

Lot or serial number
  • 011216001
  • 041216001
  • 230516001
Model or catalog number

10448808

Companies
Manufacturer
Leica Microsystems (Schweiz) Ag
Max Schmidheiny-Strasse 201
Heerbrugg
9435
SWITZERLAND