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VuPad Ophthalmic Ultrasound System

SONOMED, INC. · Model VuPad AP · UDI-DI 00896100002019

IYO Prescription

510(k) clearances

6,627

Adverse events (17 deaths)

Recalls

351

Facilities

Description

The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator 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.