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Labomed Prima Mu OPH microscope

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED · Model 6214000 · UDI-DI 08908006463336

HRM Prescription
10
510(k) clearances
370
Adverse events
7
Recalls
58
Facilities

Description

- MaxLite(TM) optics,3 step magnification: 0.6x, 1.0x, 1.6x - 27W LED illumination (cold light), 100V-240V AC universal power supply - 45° inclined binocular head, IPD 55-75mm - f=200mm CMO - WF 10x/16mm eyepieces with foldable eyeguard - Swivel arm (380mm Long, 360° rotation) and suspension arm (600mm Long, clockwise 70° and counterclockwise 180° rotation) with locking/tension control knobs and LED shut-off in park position - Motorized fine focusing; foot pedal with joystick; up/down pedals to control fine focus - Straight Carrier with tension adjustment locks - Floor stand with H-shape base on castor wheels with brakes - Blue or Green filter, dust cover, and sterilizable knob caps

Recalls

DateFirmReason
2022-11-21Leica Microsystems, Inc.There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the int
2020-11-20Haag-Streit USA IncSoftware error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not s
2019-01-02Leica Microsystems, Inc.The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
2018-07-17Alcon Research Laboratories Ltd.Potential for the optical head to detach from the stand due to the lack of thread adhesive.
2017-09-25Leica Microsystems, Inc.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 pro
2017-05-25Alcon Research, Ltd.Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
2015-08-11Alcon Research, Ltd.Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power,

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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.