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FUJIFILM

FUJIFILM CORPORATION · Model SP-900 · UDI-DI 04547410342741

IYO ODG ITX Prescription

510(k) clearances

6,553

Adverse events (17 deaths)

Recalls

352

Facilities

Description

The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode

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.