natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA device recall Z-1630-2020 · posted 2020-04-01 · Terminated
Recall details
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OMA
- Quantity affected
- 40 units
- Distribution
- Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
- Date initiated
- 2020-03-05
- Date posted
- 2020-04-01
- Date terminated
- 2021-08-09
- Location
- Oakville, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPIC BRAINZ MONITOR (K123079) | Excel-Tech Ltd. (Xltek) | 2013-05-08 |