FDA Medical Device Recalls (openFDA)
Natus Medical Incorporated: Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
- Recall number
- Z-0847-2015
- Recalling firm
- Natus Medical Incorporated
- Product
- Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
- Status
- Terminated
- Initiated
- 2014-11-19
- Posted
- 2014-12-22
- Terminated
- 2015-07-20
- 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, neoBLUE Intensity/Height (DOC 011561). Consignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided. The neoBLUE 3 system and its replacement panel sold today are not affected by this issue. If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.
- Quantity
- 1907 total (1413 in US and 494 international)
- Distribution
- worldwide
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K022196"]
- PMA numbers
- not on file
- Product code
- LBI
- Firm FEI
- 3018859
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28