Recall Z-0597-2020— NDDd Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by NDDd Medical Technologies, Inc., initiated 2017-08-15, terminated 2020-05-05. It names one FDA 510(k) clearance: K161534. Product: EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1. 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..
- Recalling firm
- NDDd Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-15
- Terminated
- 2020-05-05
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.