Natus Neurology (DBA Excel Tech., Ltd.) is recalling 3,069 units of the OBM Digital Acquisition Box (DAB), model OBM00002. This medical device, used to monitor brain activity in newborns, has electrode placement labels that were applied backwards. No injuries have been reported, but the manufacturer is voluntarily initiating this recall to correct the labeling error.
Because the electrode labels are reversed, healthcare providers might misidentify the specific location of seizure activity in infants. This could lead to an incorrect medical diagnosis or improper treatment of a newborn's condition.
Note earlier version serial numbers did not contain the sequence of 'OBM'. Recall #: Z-1925-2025.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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