# FDA recall Z-0596-2020

> **NDDd Medical Technologies, Inc.** · Class II · device recall initiated 2017-08-15.

## Product

EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

## Reason for recall

The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard.  As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.

## Distribution

The products were distributed to the following US states:  KY, MO, NY, OH, PA

## Key facts

- **Recall number:** Z-0596-2020
- **Recalling firm:** NDDd Medical Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-15
- **Report date:** 2019-12-11
- **Termination date:** 2020-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2020

## Citation

> AI Analytics. FDA recall Z-0596-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0596-2020. Source: US FDA. Licensed CC0.

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