FDA Device recall Z-0847-2015
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system by Natus Medical, citing 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 hig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0847-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-19 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Natus Medical |
| Distribution | n/a |
Product
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
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.
Identifiers
| code_info | All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012. For use only with…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Natus Medical
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea…
FDA Device · Class II · 2022-12-28 · Natus Medical - The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy an…
FDA Device · Class II · 2017-07-19 · Natus Medical - Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008
FDA Device · Class II · 2017-05-10 · Natus Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.