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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 22
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
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
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
EMAGEON
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARDIAL SOLUTIONS
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 3
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
EP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 19
GETEMED
  SUBSTANTIALLY EQUIVALENT 4
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 2
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEDICOMP
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
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 9
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 23
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Application interface becomes non-functional or program exits abnormally 93
Device Issue 68
Failure to transmit record 56
Data Issue 52
Application program issue 37
Device operates differently than expected 27
Blocked connection 25
Computer software issue 25
Communication or transmission issue 20
Device displays error message 16
Failure to cycle 14
Erratic display 11
No display or display failure 11
Connection issue 11
Loss of Data 11
Power source issue 11
Patient Data Issue 11
Noise, Audible 10
No Known Device Problem 9
Failure to pace or properly pace 8
Overheating of device or device component 7
Failure to power-up 7
Use of Device Issue 7
Disconnection 5
Image display error 5
Battery issue 5
Device emits odor 4
Difficult to remove 4
Smoking 4
Device alarm system issue 4
Artifact 4
Incorrect display 3
Loose or intermittent connection 3
Device stops intermittently 3
Output issue 3
No Information 3
Not Applicable 2
No device output 2
Incorrect measurement 2
Break 2
Decoupling 2
Use of Incorrect Control Settings 2
Arcing 2
Application program version or upgrade problem 2
Spark 2
Malposition of device 2
Failure to zero 2
Computer operating system issue 2
Calibration issue 2
Electronic property issue 2
Improper device output 2
Installation-related problem 1
Operating system version or upgrade problem 1
Problem with software installation 1
Programming issue 1
Therapeutic or diagnostic output failure 1
Improper or incorrect procedure or method 1
Low impedance 1
Incorrect software programming calculations 1
Radio signal problem 1
High Readings 1
Failure to obtain samples 1
Application network issue 1
Charred 1
Circuit Failure 1
Detachment of device component 1
Misconnection 1
Moisture damage 1
Shock, electrical 1
Electrical issue 1
Energy output to patient tissue incorrect 1
Image resolution poor 1
Oversensing 1
Parameter calculation error due to software problem 1
Difficult to position 1
Inaccurate synchronization 1
Device inoperable 1
Incorrect or inadequate result 1
Failure to sense 1
Inappropriate shock 1
Failure to select signal 1
No pacing 1
Total Device Problems 658

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 1 1 2 3 2 4 3 4 6 3 5
Class III 0 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Sep-09-2016
2 Biosense Webster, Inc. II Oct-01-2015
3 Biosense Webster, Inc. II Feb-20-2014
4 Biosense Webster, Inc. II Mar-28-2013
5 Biosense Webster, Inc. II Sep-12-2012
6 Biosense Webster, Inc. II Mar-20-2012
7 Biosense Webster, Inc. III Mar-28-2011
8 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
9 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
10 GE Healthcare, LLC II Apr-17-2013
11 GE Healthcare, LLC II Aug-14-2009
12 General Electric Medical Systems Information Technology II Aug-07-2007
13 McKesson Israel Ltd. II Jan-05-2015
14 McKesson Provider Technologies II Feb-05-2008
15 McKesson Provider Technologies - Medical Imaging Group II Jan-13-2011
16 McKesson Provider Technologies - Medical Imaging Group II Jul-09-2010
17 McKesson Provider Technologies - Medical Imaging Group II Jun-24-2010
18 Merge Healthcare, Inc. II May-02-2017
19 Merge Healthcare, Inc. II Apr-11-2017
20 Merge Healthcare, Inc. II Mar-14-2017
21 Merge Healthcare, Inc. II Feb-15-2017
22 Merge Healthcare, Inc. II Jan-24-2017
23 Merge Healthcare, Inc. II Nov-28-2016
24 Merge Healthcare, Inc. II Aug-04-2016
25 Merge Healthcare, Inc. II Dec-28-2015
26 Merge Healthcare, Inc. II Aug-06-2015
27 Merge Healthcare, Inc. II Oct-28-2014
28 Philips Medical Systems, Inc. II Aug-21-2014
29 Siemens Medical Solutions USA, Inc II May-10-2012
30 Spacelabs Healthcare, Incorporated II Aug-25-2010
31 Spacelabs Healthcare, Llc II Mar-25-2014
32 Spacelabs Healthcare, Llc II Jan-17-2013
33 Spacelabs Healthcare, Llc II Jun-20-2012
34 Spacelabs Healthcare, Llc II Jun-22-2011
35 St. Jude Medical II Apr-10-2009

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