Natus neoBLUE Phototherapy system — Class II medical device recall Z-2001-2016
Terminated recall by Natus Medical Incorporated, reported 2016-06-22, distributed nationwide. The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System an
| Recall number | Z-2001-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2016-04-11 |
| Classified | 2016-06-15 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BM, BO, CA, CH, CN, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KW, LT, LV, MA, MY, NL, NO, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VN, ZA |
| Model numbers | 001103, 001314, 002110, 010066, 040658, 040680, 040756, 040758, 040904, 040906 |
Product
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
Reason for recall
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
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-2001-2016. 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.