Andover, MA, United States
NDDd Medical Technologies, Inc. recalls
1 recall recorded since 2018, most recently on 15 August 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 August 2017
- Terminated
- 5 May 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0596-2020, Z-0597-2020
- EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.