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

Recall date

November 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1256-2020

FDA classification

Class II

Brand / firm

Edan Diagnostics

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.)