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2Mhz Monitoring Transducer - 8 foot

Novasignal Corp. · Model NA-PRB3 · UDI-DI 00850681007153

ITX Prescription

510(k) clearances

3,948

Adverse events (23 deaths)

147

Recalls

396

Facilities

Description

The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements. The transducer has the following specifications: • 2MHz ± 0.1MHz center frequency • 46mm ± 5mm focal length • 16mm active diameter • Fractional 6dB pulse-echo bandwidth = 60% to 80% • Round-trip insertion loss < 6dB • Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase

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.