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

Recall Z-0847-2015 — Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

U.S. FDA — Device Enforcement · United States · 2014-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0847-2015
Date of alert
2014-11-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Natus Medical Incorporated
Product category
device
Product type
Devices
Reported risk: Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
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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