EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function… — Class II medical device recall Z-0597-2020
Terminated recall by NDDd Medical Technologies, Inc., reported 2019-12-11, distributed in KY, MO, NY, OH, PA. The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-c
| Recall number | Z-0597-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NDDd Medical Technologies, Inc., Andover, MA, United States |
| Recall initiated | 2017-08-15 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-05-05 |
| Distributed | KY, MO, NY, OH, PA |
| Quantity | 37 devices |
| Serial numbers | 650055, 650058, 650062, 650066, 650067, 650069, 650070, 650073, 650074, 650075, 650076, 650079, 650080, 650081, 650082, 650083, 650085, 650086, 650087, 650088, 650089, 650090, 650091, 650092, 650094 and 6 more |
| Model numbers | 3100-1 |
Product
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0597-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.