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Scanmate B

DGH TECHNOLOGY INC. · Model DGH 8000 · UDI-DI 00857377006100

ITX IYO Prescription

510(k) clearances

4,015

Adverse events (23 deaths)

147

Recalls

397

Facilities

Description

The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.

Recalls

Date	Firm	Reason
2025-11-17	Sheathing Technologies Inc	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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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.