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NIHON KOHDEN AMERICA, INC. · Model AE-918P · UDI-DI 00841983100017
OMA
Prescription
10
510(k) clearances
4
Adverse events
3
Recalls
13
Facilities
Description
Neuro unit, 8 channel
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-07 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this |
| 2023-02-20 | Moberg Research, Inc. | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC |
| 2020-03-05 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functi |
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