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VuMAX HD Ophthalmic Ultrasound System

SONOMED, INC. · Model VuMAX-HD UBM · UDI-DI 00896100002194

IYO Prescription

510(k) clearances

6,627

Adverse events (17 deaths)

Recalls

351

Facilities

Description

The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It utilizes a 35 MHz and/or 50 MHz transducer with a sector scanning probe. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the high frequency ultrasound system (UBM) including the base unit, 22" LCD, water-path probe, 35 MHz transducer, keyboard and mouse, USB foot switch, immersion cups and user manual.

Recalls

Date	Firm	Reason
2026-08-06	Volcano Corp	Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2026-03-02	Civco Medical Instruments Co. Inc.	There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified
2022-01-24	Volcano Corp	Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique

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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.