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U.S. Department of Health and Human Services

Class 2 Device Recall Natus neoBLUE blanket LED Phototherapy system

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 Class 2 Device Recall Natus neoBLUE blanket LED Phototherapy systemsee related information
Date Initiated by FirmMarch 16, 2015
Date PostedApril 10, 2015
Recall Status1 Terminated 3 on December 20, 2016
Recall NumberZ-1412-2015
Recall Event ID 70810
510(K)NumberK103589 
Product Classification Unit, neonatal phototherapy - Product Code LBI
ProductNatus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
Code Information None
Recalling Firm/
Manufacturer		 Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
For Additional Information ContactTechnical Service
888-496-2887
Manufacturer Reason
for Recall		neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
FDA Determined
Cause 2		Other
ActionNatus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual. The technical bulletin asks the customer to visually and tactilely inspect the fiber optic cable connector before use, and to call Natus if they notice a failing pad. This procedure will prevent the complete degradation and therapy will not be compromised. U.S. customers should contact Natus Technical Service at 888-496-2887 with any questions regarding this notification. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or Technical_Service@natus.com.
Quantity in Commerce2611 units (1911 units in the US and 700 units outside the US)
Distributiondistributed worldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LBI
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