# FDA recall Z-1256-2020

> **Edan Diagnostics** · Class II · device recall initiated 2017-11-17.

## 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.)

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1256-2020
- **Recalling firm:** Edan Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2020-02-26
- **Termination date:** 2022-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2020

## Citation

> AI Analytics. FDA recall Z-1256-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1256-2020. Source: US FDA. Licensed CC0.

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