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U.S. Department of Health and Human Services

Class 2 Device Recall Olympic Brainz Monitor

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  Class 2 Device Recall Olympic Brainz Monitor see related information
Date Initiated by Firm March 05, 2020
Date Posted April 01, 2020
Recall Status1 Terminated 3 on August 09, 2021
Recall Number Z-1630-2020
Recall Event ID 85189
510(K)Number K123079  
Product Classification Amplitude-integrated electroencephalograph - Product Code OMA
Product natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Code Information 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
Recalling Firm/
Manufacturer		 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2568 Bristol Cir
Oakville Canada
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 40 units
Distribution Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OMA and Original Applicant = EXCEL-TECH LTD. (XLTEK)
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