Recall Z-1925-2025— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Name: FDA recall Z-1925-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Class II · Ongoing

Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2025-05-07. It names one FDA 510(k) clearance: K123079. 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: No. Reason: 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 device..

Recalling firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Classification: Class II
Status: Ongoing
Initiated: 2025-05-07
Firm location: Oakville, Canada

510(k) clearances named in this recall

1 on FDA's record

K123079 — OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek)·cleared 2013-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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: No

Reason for recall

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 device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.