10 MHz probe

VIASONIX LTD · Model 10 MHz probe · UDI-DI 07290016880076

JOP Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins

Recalls

Date	Firm	Reason
2014-06-26	Biosound Esaote, Inc.	Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature

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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.