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Labomed Prima ENT microscope with Motorized fine focus

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED · Model 6137000-100 · UDI-DI 08908006463015

FSO Prescription

510(k) clearances

165

Adverse events (1 deaths)

Recalls

Facilities

Description

Prima ENT microscope with Motorized fine focus - MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - Straight binocular head, IPD 50-75mm - f=250mm CMO with manual fine focus knob and sterilizable cap - WF 10x/18mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360 degree rotation) and suspension arm (600mm Long, 320 degree rotation) with locking/tension control knobs and LED shut-off in park position - Carrier arm and 120 degree coupling with tension adjustment locks, T-handle /Ergo Handle control - Floor stand with H-shape base on castor wheels with brakes - Yellow and Green sliding filters, dust cover, and sterilizable knob caps

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.