Edan Diagnostics recalls EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinica

Recalled February 26, 2020 · FDA recall Z-1256-2020 · Edan Diagnostics

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. · FDA Class II

Units

7 units

Sold at

U.S. Nationwide distribution in the state of CA.

Description

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.

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.)

Manufacturer(s)

Edan Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →