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Disk PPG sensor

VIASONIX LTD · Model Disk PPG sensor · UDI-DI 07290016880175

JOP Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The disk PPG sensor is round shaped and attaches to the skin with an adhesive sticker. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures, venous reflux testing, or other peripheral vascular diagnosis tests.

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.