Recall Z-0597-2020 ยท BTY Calculator, Predicted Values, Pulmonary Function
NDDd Medical Technologies, Inc.
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
| Date | Aug 15, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | Customers were contacted via email or telephone between 8/1/17 and 4/13/19. The emails including the following information: We wanted to inform you that we are planning a preventive repair for some of our recently delivered EasyOne Pro/LAB V05 devices. The repair is related to an internal shielding component against electromagnetic disturbances. In some rare cases this could potentially lead to DLCO or MBW that cannot be performed. Although the probability of occurrence is very low, we want to absolutely ensure the quality of our devices and therefore we would like to make arrangements to up |
| Quantity | 37 total devices |
| Distribution | The products were distributed to the following US states: KY, MO, NY, OH, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161534 | EasyOne Pro Respiratory Analysis System Ndd Medizintechnik AG, Feb 22, 2017 |