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Hubble Digital Vision

CAO GROUP, INC. · Model 005-00109 · UDI-DI 00872320006471

EPT Prescription

510(k) clearances

473

Adverse events

Recalls

Facilities

Description

Battery powered electronic magnification loupe and display system for use in clinical settings.

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.