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

Recall Z-2001-2016 — 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

U.S. FDA — Device Enforcement · United States · 2016-04-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2001-2016
Date of alert
2016-04-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Natus Medical Incorporated
Product category
device
Product type
Devices
Reported risk: 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.
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.

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