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FDANovember 17, 2017device

EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

What to do

FDA enforcement status: Terminated

Brands named

edan diagnosticsedan

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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