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MediWorks
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD. · Model SM620 · UDI-DI 06945087562017
10
510(k) clearances
370
Adverse events
7
Recalls
58
Facilities
Description
Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical system,observation tube and eyepieces.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-21 | Leica 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 |
| 2020-11-20 | Haag-Streit USA Inc | Software 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 |
| 2019-01-02 | Leica Microsystems, Inc. | The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. |
| 2018-07-17 | Alcon Research Laboratories Ltd. | Potential for the optical head to detach from the stand due to the lack of thread adhesive. |
| 2017-09-25 | Leica 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 |
| 2017-05-25 | Alcon 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. |
| 2015-08-11 | Alcon 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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Get your free API keyRead the docsData 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.