Recall Z-0847-2015— Natus Medical Incorporated

Name: FDA recall Z-0847-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-19

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2014-11-19, terminated 2015-07-20. It names one FDA 510(k) clearance: K022196. Product: Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.. Reason: 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..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Terminated: 2015-07-20
Firm location: Seattle, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNITNatus Medical, Inc.·cleared 2002-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.