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8 MHz probe

VIASONIX LTD · Model 8 MHz probe · UDI-DI 07290016880403

JOP Prescription
1
510(k) clearances
24
Adverse events (2 deaths)
1
Recalls
15
Facilities

Description

8 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements.

Recalls

DateFirmReason
2014-06-26Biosound 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.