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Mikroscan

MIKROSCAN TECHNOLOGIES, INC. · Model SL5-E · UDI-DI 00860002275628

510(k) clearances

Adverse events

Recalls

Facilities

Description

The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan.

Recalls

Date	Firm	Reason
2013-12-20	Zeiss, Carl Inc	Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
2013-05-28	Zeiss, Carl Inc	Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambd

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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.