Edan Diagnostics recalls EDAN Telemetry Transmitter, Model iT20 - Product Usage: The
Recalled Product
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.)
Hazard / Issue
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.
Issued by
FDA
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