natus newborn care Olympic Brainz Monitor recall
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Why was natus newborn care Olympic Brainz Monitor recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- 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
- Recall date
- April 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)