Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy — Class II medical device recall Z-0149-2016
Terminated recall by Natus Medical Incorporated, reported 2015-10-28, distributed nationwide. The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared i
| Recall number | Z-0149-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2015-08-05 |
| Classified | 2015-10-21 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 4,560 units |
| Serial numbers | 0.23998, 13201, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 18013, 18015, 18016, 18017, 18018, 18019, 18020, 18021, 18022, 18023, 18040, 18041 and 475 more |
| Model numbers | 001103, 010066 |
Product
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
Reason for recall
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0149-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.