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Focalyx Fusion

Focalyx Technologies, LLC · Model 1.7 · UDI-DI 00860003552001

LLZ

510(k) clearances

19,647

Adverse events (41 deaths)

554

Recalls

633

Facilities

Description

The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to aid targeted needle guidance in the diagnosis or treatment of prostate disease. The system is to be used by qualified physicians who are familiar with the safe operation of transrectal ultrasound and positioning devices during medical procedures involving the prostate. There are no known contraindications for the use of the device.

Recalls

Date	Firm	Reason
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.
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-19	Boston Scientific Corporation	Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu
2026-05-08	GE Medical Systems SCS	GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches
2026-03-19	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re
2026-03-05	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w

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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.