Recall Z-0847-2015 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
| Date | Dec 22, 2014 (initiated Nov 19, 2014) |
| Status | Terminated |
| 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. |
| Root cause | 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, n |
| Quantity | 1907 total (1413 in US and 494 international) |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT Natus Medical, Inc., Sep 19, 2002 |