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NDOHD High Definition Imaging System (NDOHD)

ALTARAVISION, INC. · Model 2.0 · UDI-DI 00866861000203

LLZ Prescription

510(k) clearances

19,970

Adverse events (41 deaths)

562

Recalls

638

Facilities

Description

The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic surgical procedures including, but not limited to, orthoscopic, gynecological, laparoscopic, urologic, sinuscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

Recalls

Date	Firm	Reason
2026-09-10	INTELERAD MEDICAL SYSTEMS INCORPORATED	A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or
2026-09-05	INTELERAD MEDICAL SYSTEMS INCORPORATED	Following a Chromium-based web-browser, report and displayed images may not match.
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-31	GE Healthcare	Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.

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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.