NDDd Medical Technologies Recalls EasyOne Pro Pulmonary Function Testing Devices
NDDd Medical Technologies is recalling 37 EasyOne Pro Respiratory Analysis Systems because the CO/CO2 sensor cable harness may have insufficient electromagnetic shielding.
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 source text describes a theoretical risk of sensor interference from nearby high-frequency devices without reporting any injuries, illnesses, or adverse health consequences.
Plain-English summary
NDDd Medical Technologies, Inc. is recalling 37 units of the EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1. The recall involves specific serial numbers: 550066, 550067, 550068, 550069, 550071, and 550072.
The recall was initiated because the CO/CO2 sensor cable harness may have lower electromagnetic shielding than required. This non-compliance with the IEC 60601-1-2 standard means the CO/CO2 sensor could be influenced by high frequencies emitted by devices located very close to the system.
The affected devices were distributed to the following US states: Kentucky (KY), Missouri (MO), New York (NY), Ohio (OH), and Pennsylvania (PA). Users of these devices should contact NDDd Medical Technologies, Inc. for further instructions regarding the recall.
The recalled product
- Product
- EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- Manufacturer
- NDDd Medical Technologies, Inc.
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 550066 550067 550068 550069 550071 550072
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 EasyOne Pro LAB VOS Pulmonary Function Testing Device Recall
FDA (Devices) · 2019-12-11
Same hazard · electromagnetic interference
See all →- HighSix foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighTwelve foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
- HighMonitor display cables recalled over inadequate shielding and electromagnetic interference
FDA (Devices) · 2025-10-22
- HighOperating tables recalled because interference can leave them unresponsive to controls
FDA (Devices) · 2025-09-03
- HighOlympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect
FDA (Devices) · 2024-11-06
Similar recalls
- HighNihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
FDA (Devices) · 2024-11-06
- ModerateRadiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2013-08-14
- HighZOLL AED PRO Defibrillators Recalled for Potential Energy Delivery Failure
FDA (Devices) · 2019-07-10
- HighOxygenators recalled after a unit failed carbon dioxide transfer requirements
FDA (Devices) · 2025-11-19
- HighCO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
FDA (Devices) · 2025-03-26
- HighRadiometer D788 pCO2 Membranes Recalled for Biased Measurement Results
FDA (Devices) · 2014-03-05