VuPad Ophthalmic Ultrasound System
SONOMED, INC. · Model VuPad A/B/P · UDI-DI 00896100002033
Description
The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes A-Scan, B-Scan and pachymeter capabilities. 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 A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. 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 tablet, 12 MHz B-probe, 10 MHz A-probe, 20 MHz pachymetry probe, power supply, 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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