medical Class II Updated 2020-02-26

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
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