Second generation neoBLUE LED Phototherapy Light — Class II medical device recall Z-1924-2017
Terminated recall by Natus Medical Incorporated, reported 2017-05-10, distributed nationwide. The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will elim
| Recall number | Z-1924-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2017-04-03 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BM, CA, CH, CO, DE, DK, ES, GB, GR, HR, HU, ID, IL, IN, IT, JP, KE, KW, LT, MA, NO, PE, PH, PL, PT, RO, RU, SE, SG, TR, TW, ZA |
| Model numbers | 010066, 040658, 040680, 040756, 040758, 040904, 040906 |
Product
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
Reason for recall
The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
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-1924-2017. 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.