Digital Acquisition Box devices recalled due to backwards electrode placement labels
Natus Neurology is recalling OBM00002 Digital Acquisition Box devices due to electrode placement labels applied backwards, which may cause misdiagnosis of seizure location in monitored neonates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a functional labeling error that could lead to diagnostic errors in vulnerable neonates, but no illnesses or injuries have been reported. Per the rubric, this qualifies as High (score 3) as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Natus Neurology (operating as Excel Tech., Ltd. / XLTEK) is recalling the OBM00002 Digital Acquisition Box (DAB). This medical device is used to monitor brain electrical activity. Approximately 3,069 units have been distributed worldwide, including throughout the United States and numerous countries internationally.
The electrode placement labels on the device were applied backwards. This error in labeling affects the device's ability to correctly identify electrode positions during monitoring.
The affected units were distributed to hospitals and medical facilities worldwide. This recall specifically impacts neonates (newborns) being monitored with this device. According to the FDA, the backwards electrode labels may ultimately lead to misdiagnosis of seizure location, which could affect clinical decision-making regarding patient care.
The recalled product
- Product
- Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: N
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Category
- Medical Device
- Hazard
- mis-labeling
- misdiagnosis-risk
Distribution
Distributed nationwide across the United States.
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