Recall Z-0149-2016— Natus Medical Incorporated

Name: FDA recall Z-0149-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-05

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2015-08-05, terminated 2016-03-17. It names one FDA 510(k) clearance: K022196. Product: Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103. Reason: The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Terminated: 2016-03-17
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

Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103

Reason for recall

The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.

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