Recall Z-2001-2016— Natus Medical Incorporated

Name: FDA recall Z-2001-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-11

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2016-04-11, terminated 2016-12-14. It names one FDA 510(k) clearance: K022196. Product: 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. Reason: 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..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2016-04-11
Terminated: 2016-12-14
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 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

Reason for recall

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.

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