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Focalyx Fusion 1.7Recalls & reported problems

Focalyx Technologies, LLC · 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. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 23, 2025Open, Classified

    Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

    Z-1243-2026 · Root cause: Software change control · FDA record ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.