Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1412-2015 — Natus neoBLUE blanket LED Phototherapy system which includes the following items: 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

U.S. FDA — Device Enforcement · United States · 2015-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1412-2015
Date of alert: 2015-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Natus Medical Incorporated
Product category: device
Product type: Devices

Reported risk: neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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