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Seiler Precision Microscopes

SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED · Model 3DV-100 · UDI-DI 00852728008079

EPT

510(k) clearances

474

Adverse events

Recalls

Facilities

Description

The 3D Surgical Microscopes are produced and sold by Seiler Instrument & Manufacturing Co., Inc. There are many types of medical procedures that benefit from the high magnification provided by a surgical microscope. The microscope offers the user an illuminated and magnified view of the field of interest. Floor, Wall, and Ceiling support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes a LED light source to illuminate the area within the field of view. A light guide/cable transfers the output from the light source to the optic pod. The light is then projected through the objective lens to the area of interest, providing relatively shadow-free illumination. The light source also provides two DC outputs to provided power to the 3D display and other electronics. The user must wear polarized 3D glasses while viewing the 3D display to view the illuminated and magnified view of the field of interest. Focus, magnification, and brightness controls offer image options to the user.

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
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
2020-05-20	Leica Microsystems, Inc.	Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
2019-07-31	Haag-Streit USA Inc	software error in the central control unit of the floor stand.
2019-07-31	Haag-Streit USA Inc	software error in the central control unit of the floor stand.
2019-07-31	Haag-Streit USA Inc	software error in the central control unit of the floor stand.
2018-09-04	Leica Microsystems, Inc.	The firm received complaints that the instrument tipped over when the swing arm was fully extended.
2018-06-04	Leica Microsystems, Inc.	Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot
2017-01-01	Seiler Instr. & Mfg. Co. Inc.	The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
2013-04-18	Carl Zeiss Meditec, Inc.	Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to

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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.