Recall Z-1925-2025 ยท OMA Amplitude-Integrated Electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
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
| Date | Jun 9, 2025 (initiated May 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Employee error |
| Action | On May 7, 2025, the firm began notifying customers through "Urgent Medical Device Recall" letters. Customers are instructed to check their Olympic Brainz Monitor stock and determine if they have any devices with the incorrect label orientation. Immediately cease use of incorrectly labeled product and quarantine until you receive return instructions from Natus. Customers with incorrect product labelling will be provided with replacement device(s). If you have any questions regarding this notice, please contact FCA@Natus.com. |
| Quantity | 3069 |
| Distribution | Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123079 | OLYMPIC BRAINZ MONITOR Excel-Tech Ltd. (Xltek), May 8, 2013 |