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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computer, diagnostic, programmable
Regulation Description Programmable diagnostic computer.
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 20
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CAMBRIDGE HEART, INC.
  SUBSTANTIALLY EQUIVALENT 7
CHEETAH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DATADANCER MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC MONITORING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
EMAGEON
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARDIAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
EP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 19
GETEMED
  SUBSTANTIALLY EQUIVALENT 2
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVISION A/S
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
NON-INVASIVE MONITORING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NORTHEAST MONITORING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORANGE INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ROZINN ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 14
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 6
Smoking 3
Spark 2
Computer software issue 2
No Known Device Problem 2
Difficult to remove 2
Application interface becomes non-functional or program exits abnormally 1
No display or display failure 1
Shock, electrical 1
Energy output to patient tissue incorrect 1
Image display error 1
Device emits odor 1
Communication or transmission issue 1
Arcing 1
Device displays error message 1
Total Device Problems 26

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 1 2 3 2 4 3
Class III 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Mar-28-2013
2 Biosense Webster, Inc. II Sep-12-2012
3 Biosense Webster, Inc. II Mar-20-2012
4 Biosense Webster, Inc. III Mar-28-2011
5 GE Healthcare II Aug-14-2009
6 GE Healthcare, LLC II Apr-17-2013
7 General Electric Medical Systems Information Technology II Aug-07-2007
8 McKesson Provider Technologies II Feb-05-2008
9 McKesson Provider Technologies - Medical Imaging Group II Jan-13-2011
10 McKesson Provider Technologies - Medical Imaging Group II Jul-09-2010
11 McKesson Provider Technologies - Medical Imaging Group II Jun-24-2010
12 Siemens Medical Solutions USA, Inc II May-10-2012
13 Spacelabs Healthcare, Incorporated II Aug-25-2010
14 Spacelabs Healthcare, Llc II Jan-17-2013
15 Spacelabs Healthcare, Llc II Jun-20-2012
16 Spacelabs Healthcare, Llc II Jun-22-2011
17 St. Jude Medical II Apr-10-2009

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