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Labomed Stella OPH microscope with wall mount

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED · Model 6219101 · UDI-DI 08908006463268

HRM Prescription
10
510(k) clearances
374
Adverse events
7
Recalls
59
Facilities

Description

'- Maxlite coated Motorized 5 Step Zoom, 0.4X, 0.6X, 1.0X, 1.6X, 2.5X - Galilean optical system with high resolution, high depth of field and perfect RedReflex . - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 0° - 210° tiltable binocular head, f-140mm. IPD 49-78mm, configured with DBS (Double beam splitter ), Double iris, MaxLite(TM) optics - f=200mm CMO - WF 10x/18mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (470mm Long, + 180° rotatable altogether with column for better stability and balancing). - suspension arm (1000mm Long, + 180° rotation) with locking knobs, tension control knobs, downward limit stop and LED shut-off in park position - Motorized XYZ carrier with autolock tiltable mechanism, XY reset button and provision for fundus viewing attachment (BIOM image invertor). - 10 function wired foot switch for XY & Z axis movements, Magnification changer and intensity control. - Wall mount - Flip in/out blue blocking yellow filter. Retro illumination contrast stops and retinal protection device. Red free green filter. - can be upgraded with Assistant Viewing Attachment, Camera Adapter and iphone adapters

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.