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U.S. Department of Health and Human Services

Class 2 Device Recall Natus Blue Light, neoBLUE

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 Class 2 Recall
Natus Blue Light, neoBLUE
see related information
Date Posted November 24, 2009
Recall Status1 Terminated on September 22, 2011
Recall Number Z-0420-2010
Recall Event ID 53681
Premarket Notification
510(K) Number
K022196 
Product Classification Unit, Neonatal Phototherapy - Product Code LBI
Product The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
Code Information Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish). AFFECTED SERIAL NUMBERS: 60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656.
Recalling Firm/
Manufacturer
Natus Medical Incorporated
5900 1st Ave S
Seattle, Washington 98108-3248
Manufacturer Reason
for Recall
The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp. Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus. International distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees. Replacements will be sent to the distribution partner for their consignees.
Quantity in Commerce 2127
Distribution Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LBI and Original Applicant = NATUS MEDICAL, INC.
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