Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1925-2025 — 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

U.S. FDA — Device Enforcement · Canada · 2025-05-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1925-2025
Date of alert
2025-05-07
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00382830010825
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.