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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 23
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 103
Device Issue 81
Failure to transmit record 68
Data Issue 65
Application program issue 37
Device operates differently than expected 29
Computer software issue 27
Blocked connection 25
Communication or transmission issue 25
Device displays error message 16
No display or display failure 16
Failure to cycle 14
Connection issue 13
Power source issue 13
No Known Device Problem 11
Patient Data Issue 11
Loss of Data 11
Erratic display 11
Noise, Audible 10
Failure to power-up 9
Overheating of device or device component 8
Difficult to remove 8
Failure to pace or properly pace 8
No Information 8
Incorrect measurement 7
Use of Device Issue 7
Battery issue 7
Improper device output 5
Artifact 5
Disconnection 5
Image display error 5
Device alarm system issue 4
Device emits odor 4
Smoking 4
Output issue 4
Not Applicable 4
No code available 3
Device stops intermittently 3
Loose or intermittent connection 3
Incorrect display 3
Break 2
Decoupling 2
Use of Incorrect Control Settings 2
No device output 2
Failure to zero 2
Spark 2
Malposition of device 2
Application network issue 2
Electronic property issue 2
Failure of device to self-test 2
Arcing 2
Application program version or upgrade problem 2
Computer operating system issue 2
Calibration issue 2
Impedance issue 1
Installation-related problem 1
No fail-safe mechanism 1
Electromagnetic compatibility issue 1
Incorrect software programming calculations 1
Radio signal problem 1
High Readings 1
Failure to obtain samples 1
Improper or incorrect procedure or method 1
Electro-static discharge 1
Low impedance 1
Inaccurate synchronization 1
Device inoperable 1
Oversensing 1
Misconnection 1
Moisture damage 1
Parameter calculation error due to software problem 1
Difficult to position 1
Power Conditioning Issue 1
Incorrect or inadequate result 1
Failure to sense 1
Inappropriate shock 1
Failure to read input signal 1
Failure to select signal 1
Charred 1
Circuit Failure 1
Detachment of device component 1
Shock, electrical 1
Electrical issue 1
Energy output to patient tissue incorrect 1
Image resolution poor 1
No pacing 1
Operating system version or upgrade problem 1
Problem with software installation 1
Programming issue 1
Therapeutic or diagnostic output failure 1
Total Device Problems 764

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 10
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 CardioTek BV II Jun-30-2017
9 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
10 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
11 GE Healthcare, LLC II Apr-17-2013
12 GE Healthcare, LLC II Aug-14-2009
13 General Electric Medical Systems Information Technology II Aug-07-2007
14 McKesson Israel Ltd. II Jan-05-2015
15 McKesson Provider Technologies II Feb-05-2008
16 McKesson Provider Technologies - Medical Imaging Group II Jan-13-2011
17 McKesson Provider Technologies - Medical Imaging Group II Jul-09-2010
18 McKesson Provider Technologies - Medical Imaging Group II Jun-24-2010
19 Merge Healthcare, Inc. II Jul-10-2017
20 Merge Healthcare, Inc. II Jun-29-2017
21 Merge Healthcare, Inc. II May-02-2017
22 Merge Healthcare, Inc. II Apr-11-2017
23 Merge Healthcare, Inc. II Mar-14-2017
24 Merge Healthcare, Inc. II Feb-15-2017
25 Merge Healthcare, Inc. II Jan-24-2017
26 Merge Healthcare, Inc. II Nov-28-2016
27 Merge Healthcare, Inc. II Aug-04-2016
28 Merge Healthcare, Inc. II Dec-28-2015
29 Merge Healthcare, Inc. II Aug-06-2015
30 Merge Healthcare, Inc. II Oct-28-2014
31 Philips Medical Systems, Inc. II Aug-21-2014
32 Siemens Medical Solutions USA, Inc II Jul-06-2017
33 Siemens Medical Solutions USA, Inc II May-24-2017
34 Siemens Medical Solutions USA, Inc II May-10-2012
35 Spacelabs Healthcare, Incorporated II Aug-25-2010
36 Spacelabs Healthcare, Llc II Mar-25-2014
37 Spacelabs Healthcare, Llc II Jan-17-2013
38 Spacelabs Healthcare, Llc II Jun-20-2012
39 Spacelabs Healthcare, Llc II Jun-22-2011
40 St. Jude Medical II Apr-10-2009

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