The Recall Desk
ModerateFDA (Devices)·Z-0596-2020·Announced 2019-12-11

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.

What this means for you

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.
Category
Medical Device — Pulmonary Function Testing
Hazard
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

Distributed in 5 states:

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.

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Same hazard · electromagnetic interference

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