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Detachable PPG Clip sensor

VIASONIX LTD · Model Detachable PPG Clip sensor · UDI-DI 07290016880441

JOP Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures 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.