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Surgical 3D Video Microscope KestrelView II

MITAKA KOHKI CO., LTD. · Model KV2 · UDI-DI 04589698450206

EPT
10
510(k) clearances
473
Adverse events
14
Recalls
76
Facilities

Description

The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.

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
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
2020-05-20Leica Microsystems, Inc.Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2019-07-31Haag-Streit USA Incsoftware error in the central control unit of the floor stand.
2018-09-04Leica Microsystems, Inc.The firm received complaints that the instrument tipped over when the swing arm was fully extended.
2018-06-04Leica 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
2017-01-01Seiler 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.
2013-04-18Carl 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.