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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, carbon-dioxide, cutaneous
Regulation Description Cutaneous carbon dioxide (PcCO2) monitor.
Product CodeLKD
Regulation Number 868.2480
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 2
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 19
Fracture 4
Break 2
Entrapment of device or device component 2
Malposition of device 2
Material deformation 2
Device operates differently than expected 1
Dislodged or dislocated 1
Positioning Issue 1
No Information 1
Device alarm system issue 1
Detachment of device component 1
Difficult to remove 1
Sticking 1
Use of Device Issue 1
High Readings 1
Failure to disconnect 1
Total Device Problems 42

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 0 1 1 2 0 0 3 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Philips Healthcare Inc. II Apr-08-2010
2 Philips Medical Systems, Inc. II Jan-16-2015
3 Radiometer America Inc II May-02-2016
4 Radiometer America Inc II Aug-19-2015
5 Radiometer America Inc II Dec-01-2011
6 SenTec AG II Oct-17-2016
7 SenTec AG II Apr-22-2015
8 Sentec AG II Nov-22-2012
9 Sentec AG II Aug-13-2012

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