Natus Medical Incorporated: Medical Device Recall in 2014 - (Recall #: Z-0847-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

Product Classification:

Class II

Date Initiated: November 19, 2014

Date Posted: December 31, 2014

Recall Number: Z-0847-2015

Event ID: 69820

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.

Status: Terminated

Product Quantity: 1907 total (1413 in US and 494 international)

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)

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated