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U.S. Department of Health and Human Services

Class 2 Device Recall Natus neoBLUE 2 Phototherapy system

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  Class 2 Device Recall Natus neoBLUE 2 Phototherapy system see related information
Date Initiated by Firm November 19, 2014
Date Posted December 22, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-0847-2015
Recall Event ID 69820
510(K)Number K022196  
Product Classification Neonatal phototherapy unit - Product Code LBI
Product Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Code Information All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)  
Recalling Firm/
Manufacturer		 Natus Medical Incorporated
5900 1st Ave S
Seattle WA 98108-3248
For Additional Information Contact Technical Service
888-496-2887
Manufacturer Reason
for Recall		 Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
FDA Determined
Cause 2		 Other
Action Natus Medical has begun mailing the Urgent Recall Notification/Field Safety Notice neoBLUE LED Board Replacements letter (DOC-012737B), dated November 5, 2014, to US consignees. Natus Medical also send the Product Advisory neoBLUE LED Board Replacements letter (DOC-0012738), dated October 30, 2014, to International Distribution Partners. Both US and International consignees also received the TECHNICAL BULLETIN LED Board Kit, neoBLUE 2 LED Phototherapy System, p/n: 001840, Treatment Intensity with revised LED board for neoBLUE 2 systems (p/n: 040904 & 040906) [DOC 008353]; and the Label, neoBLUE Intensity/Height (DOC 011561). Consignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided. The neoBLUE 3 system and its replacement panel sold today are not affected by this issue. If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.
Quantity in Commerce 1907 total (1413 in US and 494 international)
Distribution worldwide
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 = LBI and Original Applicant = NATUS MEDICAL, INC.
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