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SEILER MEDICAL DIVISION

SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED · Model AA3-ENT2-LED220 · UDI-DI 00852728008239

EPT

510(k) clearances

473

Adverse events

Recalls

Facilities

Description

The Alpha Air Series Microscopes 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, Ceiling, and Tabletop support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes an integrated LED light source to illuminate the area within the microscopes field of view.

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.