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.)

Reason: 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.

Code information: Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002

Distribution pattern: U.S. Nationwide distribution in the state of CA.