Recall Z-1630-2020 ยท OMA Amplitude-Integrated Electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
| Date | Apr 1, 2020 (initiated Mar 5, 2020) |
| Status | Terminated |
| Reason | 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 functionality of the affected items. |
| Root cause | Nonconforming Material/Component |
| Action | Natus initiated the recall by letter on 03/05/2020. the firm asked customers to return the affected units to Natus Medical Incorporated, 5900 First Avenue, Seattle, WA 98108, USA. Testing will be performed by Natus on the returned unit and will be returned to the consignee following completion of testing. Natus will provide a temporary replacement unit during this time. |
| Quantity | 40 units |
| Distribution | Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123079 | OLYMPIC BRAINZ MONITOR Excel-Tech Ltd. (Xltek), May 8, 2013 |