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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, neonatal phototherapy
Regulation Description Neonatal phototherapy unit.
Product CodeLBI
Regulation Number 880.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LUMITEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDELA
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIX I.C.S.A.
  SUBSTANTIALLY EQUIVALENT 3
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Failure to service 2
Improper or incorrect procedure or method 2
Break 2
Maintenance does not comply to manufacturers recommendations 2
No Known Device Problem 2
Misassembled by Users 1
Component incompatible 1
User used incorrect product for intended use 1
Component or accessory incompatibility 1
Incompatibility problem 1
Total Device Problems 15

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 1 0 1 3 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. II Jul-06-2012
2 Natus Medical Incorporated II Jun-15-2016
3 Natus Medical Incorporated II Oct-21-2015
4 Natus Medical Incorporated II Apr-10-2015
5 Natus Medical Incorporated II Dec-22-2014
6 Natus Medical Incorporated II Nov-24-2009
7 Physician Engineered Products, Inc. II Aug-31-2015

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