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Recall Observatory FDA recall evidence

Device product

EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

Z-0526-2013

November 15, 2012

Class II

Product summary

Firm
EEG Info
Event
Event 63824
Status
Terminated
Classification
Class II
Quantity
1308 units
Official record key
device-enforcement:Z-0526-2013

Official wording

Reason: EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

Code information: Serial Number: 0001-3343.

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling