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Recall Observatory FDA recall evidence

Device product

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

Z-0847-2015

November 19, 2014

Class II

Product summary

Firm
Natus Medical Incorporated
Event
Event 69820
Status
Terminated
Classification
Class II
Quantity
1907 total (1413 in US and 494 international)
Official record key
device-enforcement:Z-0847-2015

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.