Natus neoBLUE blanket LED Phototherapy system — Class II medical device recall Z-0770-2017
Terminated recall by Natus Medical Incorporated, reported 2016-12-21, distributed nationwide. neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to cu
| Recall number | Z-0770-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2016-10-28 |
| Classified | 2016-12-15 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2021-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, CA, CH, CL, CR, CZ, DE, DK, EC, ES, FI, FR, GB, HK, HR, ID, IL, IQ, IT, KR, KW, LV, MY, NG, NL, NO, PA, PE, PH, PL, PT, RO, RU, SA, SG, SI, SK, TH, TR, TW, UY, VN, ZA |
| Reason classes | specification failure |
Product
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
Reason for recall
neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
Machine access
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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.