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VuPad Ophthalmic Ultrasound System

SONOMED, INC. · Model VuPad B/UBM · UDI-DI 00896100002156

IYO Prescription

510(k) clearances

6,553

Adverse events (17 deaths)

Recalls

352

Facilities

Description

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch 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.