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Labomed Prima DNT Microscope Mobile Mount

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED · Model 6138000 · UDI-DI 08908006463022

FSO Prescription

510(k) clearances

165

Adverse events (1 deaths)

Recalls

Facilities

Description

The LABOMED Prima DNT is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of dentistry surgeries by providing magnified view of the surgical field without compromise to performance. The microscope provides extremely high optical image quality, good depth of focus and wide field of view for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help to reduce the Surgeon's work fatigue and allow comfortable use over long period. Salient features of this Microscope are: 1. The observation head can easily be positioned with the help of a suspension arm. 2. An advanced 5-step magnification changer allows an optimal magnification for a particular surgery from five different magnifications. 3. Cold light illumination with a high intensity 50W LED lamp is provided in magnichanger for proper illumination. The illumination is further adjustable up to its most suitable brightness using intensity control knob suitably located at the suspension arm, and is easily approachable to the surgeon. 4. When the microscope is not in use, the suspension arm can be folded over the main body to store it compactly. 5. Dual iris Diaphragm allows greater depth of field particularly valuable for photography. 6. Rigid H-form base with castor wheels provides greater stability as well as mobility to the instrument. INTENDED USE Prima Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field.

Recalls

Date	Firm	Reason
2024-05-13	Aesculap Inc	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.
2023-08-18	Carl Zeiss Suzhou Co., Ltd.	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 inj
2022-08-26	Leica Microsystems, Inc.	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 o
2022-08-26	Leica Microsystems, Inc.	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 o
2022-08-26	Leica Microsystems, Inc.	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 o
2022-08-26	Leica Microsystems, Inc.	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 o
2022-07-14	Aesculap Implant Systems LLC	Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
2021-11-03	Leica Microsystems, Inc.	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,
2021-02-19	Aesculap Implant Systems LLC	Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
2016-01-11	Leica Microsystems, Inc.	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.