The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
FDA Recall Z-0420-2010 · Posted 2009-11-24
Advertisement
Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeLBI
Date Initiated2009-10-01
Date Terminated2011-09-22
Product Quantity2127
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement