FDA Device recall Z-0596-2020
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1 by Nddd Medical Technologies, citing 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 lowe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0596-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-15 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nddd Medical Technologies |
| Distribution | KY, MO, NY, OH, PA |
Product
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
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.
Identifiers
| code_info | Serial Numbers: 550066 550067 550068 550069 550071 550072 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2020%22
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