Recalls for Microscope, Surgical, General & Plastic Surgery

Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.

Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.

An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.

The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.

The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.

The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.

Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: