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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device display, cathode-ray tube, medical
Regulation Description Medical cathode-ray tube display.
Product CodeDXJ
Regulation Number 870.2450
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
CURLVIEW IGT, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SORIN
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYSTEMSONE
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device packaging compromised 2
Electrical shorting 1
Improper alarm 1
Wireless communication issue 1
Device alarm system issue 1
Break 1
Charred 1
No display or display failure 1
Dose calculation error due to software problem 1
Unsealed device packaging 1
Failure to power-up 1
Incorrect or inadequate result 1
Smoking 1
Telemetry discrepancy 1
Improper or incorrect procedure or method 1
Tear, rip or hole in device packaging 1
Split 1
Loss of Data 1
Device operates differently than expected 1
Total Device Problems 20

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 3 4 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Philips Healthcare Inc. II Aug-31-2011
2 Philips Healthcare Inc. II Nov-18-2010
3 Philips Healthcare Inc. II Nov-24-2009
4 Philips Healthcare Inc. II Jul-07-2009
5 Philips Healthcare Inc. II May-27-2009
6 Philips Medical Systems II Aug-23-2008
7 Spacelabs Healthcare, Incorporated II Nov-02-2010
8 Spacelabs Healthcare, Incorporated II Jan-19-2010
9 Spacelabs Healthcare, Llc II Dec-14-2010

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