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Terminated

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

FDA Recall Z-0149-2016 · Posted 2015-10-21

Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeLBI
Date Initiated2015-08-05
Date Terminated2016-03-17
Product Quantity4560 units

Reason for Recall

The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.

Firm Action

Natus Medical starting sending the Product Labeling Change NeoBlue LED Phototherapy System letter, dated August 2015, to all affected customers. The firm also attached the electronic copy of the revised User Manual with the letter. Customers are informed that the user and service manuals related to intensity for the neoBLUE 3 system are revised. Also, while the neoBLUE system does allow the light output to be adjusted with the potentiometers to accommodate different treatment heights, the firm removed the phrase "adjustable to >50 W/cm/nm" from the specifications. If you would like a CD disk containing the updated User Manual and the Service Manual at no charge, please call Natus Technical Service at 888-496-2887.

Root Cause

No Marketing Application

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022196NATUS BLUE LIGHT PHOTOTHERAPY UNITNatus Medical, Inc. · 2002-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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