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Unifi Workspace

Hologic, Inc. · Model Unifi Workspace V1.0 · UDI-DI 15420045511859

LLZ Prescription

510(k) clearances

19,970

Adverse events (41 deaths)

562

Recalls

638

Facilities

Description

Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data.

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.