Z-0847-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 19, 2014
- Termination Date
- July 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1907 total (1413 in US and 494 international)
Product Description
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
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.
Distribution Pattern
worldwide
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)