The Recall Desk
ModerateFDA (Devices)·Z-0526-2013·Announced 2012-12-26

EEG Info Recalls EEG NeuroAmp Devices Due to Mislabeling

EEG Info is recalling EEG NeuroAmp devices because of a potential risk associated with mislabeling.

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 and involves mislabeling, which aligns with the rubric for moderate severity involving labeling errors.

Plain-English summary

EEG Info, Inc. is recalling the EEG NeuroAmp device, including models CS 10090 and CS 10137, used for biofeedback and relaxation. The recall involves 1,308 units with serial numbers ranging from 0001 to 3343.

The company identified a potential risk associated with the mislabeling of certain devices. The affected units were distributed nationwide.

Consumers should stop using the recalled devices and contact EEG Info for further instructions.

The recalled product

Product
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Manufacturer
EEG Info
Affected units
1,308

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 Number: 0001-3343.

Distribution

Distributed nationwide across the United States.