Digital Acquisition Box Electrode Placement Labels Applied Backwards
Natus Neurology has recalled the OBM00002 OBM DAB (Digital Acquisition Box) because electrode placement labels were applied backwards. This may lead to misdiagnosis of seizure location in neonates monitored with the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The FDA classified this as Class II. The hazard involves risk of patient harm through misdiagnosis in a vulnerable population (neonates); however, no illnesses or injuries have been reported in the source text, which places it at score 3 per the rubric.
Plain-English summary
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling the OBM00002 OBM DAB (Digital Acquisition Box) due to a labeling error. Electrode placement labels on the device were applied backwards.
This error may ultimately lead to misdiagnosis of seizure location in neonates being monitored with this device. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries.
Approximately 3,069 units with serial numbers 001 through OBM00002H3613 are affected. Users should contact Natus Neurology for instructions on how to proceed with their devices.
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…
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Affected units
- 3,069
Distribution
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