NDDd EasyOne Pro LAB VOS Pulmonary Function Testing Device Recall
NDDd Medical Technologies is recalling 37 EasyOne Pro LAB VOS devices due to potential non-compliance with electromagnetic shielding standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a theoretical non-compliance with electromagnetic shielding standards without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
NDDd Medical Technologies, Inc. is recalling 37 EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Devices, Model 3100-1. The recall is due to a potential defect in the CO/CO2 sensor cable harness, which may have lower electromagnetic shielding than required. This could result in non-compliance with the IEC 60601-1-2 standard.
The lower electromagnetic shielding might allow the CO/CO2 sensor to be influenced by high frequencies emitted by very close devices. The affected products were distributed to the following US states: Kentucky, Missouri, New York, Ohio, and Pennsylvania.
Consumers should check their device serial numbers against the list provided in the official recall notice. If the serial number matches, they should contact NDDd Medical Technologies for further instructions on how to proceed with the recall.
The recalled product
- Product
- EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
- Manufacturer
- NDDd Medical Technologies, Inc.
- Affected units
- 37
Distribution
Part of a larger recall action
This product is one of 2 recalled by NDDd Medical Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · NDDd Medical Technologies, Inc.
See all →- ModerateNDDd Medical Technologies Recalls EasyOne Pro Pulmonary Function Testing Devices
FDA (Devices) · 2019-12-11
Same hazard · electromagnetic interference
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