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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
| 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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Get your free API keyRead the docsData 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.
