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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 3
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
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 3
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 84
Device Issue 56
Failure to transmit record 44
Data Issue 41
Application program issue 37
Device operates differently than expected 27
Computer software issue 24
Blocked connection 23
Communication or transmission issue 17
Device displays error message 16
Failure to cycle 12
Erratic display 11
Connection issue 11
Loss of Data 11
Patient Data Issue 11
No display or display failure 9
Failure to pace or properly pace 8
Noise, Audible 8
Overheating of device or device component 7
No Known Device Problem 7
Use of Device Issue 7
Power source issue 5
Image display error 5
Disconnection 5
Failure to power-up 5
Smoking 4
Device emits odor 4
Device alarm system issue 4
Artifact 4
Incorrect display 3
Loose or intermittent connection 3
Output issue 3
Arcing 2
Computer operating system issue 2
Electronic property issue 2
Improper device output 2
Failure to zero 2
Spark 2
Malposition of device 2
Calibration issue 2
Incorrect measurement 2
Break 2
Decoupling 2
Use of Incorrect Control Settings 2
Device stops intermittently 2
Difficult to remove 2
Not Applicable 2
No Information 2
No pacing 1
Incorrect or inadequate result 1
Failure to sense 1
Inappropriate shock 1
Failure to select signal 1
Inaccurate synchronization 1
Incorrect software programming calculations 1
Radio signal problem 1
Image resolution poor 1
Oversensing 1
Parameter calculation error due to software problem 1
Difficult to position 1
Charred 1
Circuit Failure 1
Detachment of device component 1
Misconnection 1
Moisture damage 1
Shock, electrical 1
Energy output to patient tissue incorrect 1
Application program version or upgrade problem 1
Application network issue 1
Improper or incorrect procedure or method 1
Low impedance 1
High Readings 1
Failure to obtain samples 1
Failure to disconnect 1
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
Total Device Problems 579

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 2
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 Feb-15-2017
19 Merge Healthcare, Inc. II Jan-24-2017
20 Merge Healthcare, Inc. II Nov-28-2016
21 Merge Healthcare, Inc. II Aug-04-2016
22 Merge Healthcare, Inc. II Dec-28-2015
23 Merge Healthcare, Inc. II Aug-06-2015
24 Merge Healthcare, Inc. II Oct-28-2014
25 Philips Medical Systems, Inc. II Aug-21-2014
26 Siemens Medical Solutions USA, Inc II May-10-2012
27 Spacelabs Healthcare, Incorporated II Aug-25-2010
28 Spacelabs Healthcare, Llc II Mar-25-2014
29 Spacelabs Healthcare, Llc II Jan-17-2013
30 Spacelabs Healthcare, Llc II Jun-20-2012
31 Spacelabs Healthcare, Llc II Jun-22-2011
32 St. Jude Medical II Apr-10-2009

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