Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EDAN Telemetry Transmitter Recalled by Edan Diagnostics Due to Firm became aware that it distributed 7 units...

Date: November 17, 2017
Company: Edan Diagnostics
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Edan Diagnostics directly.

Affected Products

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.)

Quantity: 7 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edan Diagnostics

Edan Diagnostics has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report