natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
- Recall Initiated
- March 5, 2020
- Posted
- April 1, 2020
- Terminated
- August 9, 2021
- Recall Number
- Z-1630-2020
- Quantity
- 40 units
- Firm Location
- Oakville Canada
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.
Distribution
Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
Lot / Code Info
Serial Numbers: OBM00002G2119, OBM00002G2130, OBM00002G2131, OBM00002G2132, OBM00002G2133, OBM00002G2134, OBM00002G2135, OBM00002G2136, OBM00002G2137, OBM00002G2138, OBM00002G2139, OBM00002G2140, OBM00002G2141, OBM00002G2142, OBM00002G2143, OBM00002G2144, OBM00002G2145, OBM00002G2146, OBM00002G2147, OBM00002G2148, OBM00002G2149, OBM00002G2150, OBM00002G2151, OBM00002G2152, OBM00002G2153, OBM00002G2154, OBM00002G2155, OBM00002G2156, OBM00002G2157, OBM00002G2158, OBM00002G2159, OBM00002G2160, OBM00002G2161, OBM00002G2162, OBM00002G2163, OBM00002G2164, OBM00002G2165, OBM00002G2166, OBM00002G2167, OBM00002G2168
Root Cause
Nonconforming Material/Component
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.