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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 80
Device Issue 52
Data Issue 41
Failure to transmit record 40
Application program issue 33
Device operates differently than expected 27
Computer software issue 24
Blocked connection 20
Communication or transmission issue 17
Device displays error message 16
Failure to cycle 12
Loss of Data 11
Erratic display 11
Patient Data Issue 11
Connection issue 10
No display or display failure 9
Failure to pace or properly pace 8
Noise, Audible 8
Overheating of device or device component 7
Use of Device Issue 7
No Known Device Problem 7
Power source issue 5
Disconnection 5
Failure to power-up 5
Image display error 5
Device emits odor 4
Device alarm system issue 4
Smoking 4
Artifact 4
Loose or intermittent connection 3
Incorrect display 3
Calibration issue 2
Output issue 2
Break 2
No Information 2
Malposition of device 2
Use of Incorrect Control Settings 2
Computer operating system issue 2
Failure to zero 2
Arcing 2
Incorrect measurement 2
Not Applicable 2
Decoupling 2
Electronic property issue 2
Improper device output 2
Device stops intermittently 2
Difficult to remove 2
Spark 2
Programming issue 1
Problem with software installation 1
Failure to sense 1
Inaccurate synchronization 1
Energy output to patient tissue incorrect 1
Incorrect software programming calculations 1
Oversensing 1
Low impedance 1
Misconnection 1
Inappropriate shock 1
Parameter calculation error due to software problem 1
Improper or incorrect procedure or method 1
Therapeutic or diagnostic output failure 1
No pacing 1
High Readings 1
Circuit Failure 1
Failure to obtain samples 1
Detachment of device component 1
Shock, electrical 1
Operating system version or upgrade problem 1
Radio signal problem 1
Installation-related problem 1
Application network issue 1
Failure to select signal 1
Moisture damage 1
Difficult to position 1
Charred 1
Incorrect or inadequate result 1
Total Device Problems 555

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 0
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 Nov-28-2016
19 Merge Healthcare, Inc. II Aug-04-2016
20 Merge Healthcare, Inc. II Dec-28-2015
21 Merge Healthcare, Inc. II Aug-06-2015
22 Merge Healthcare, Inc. II Oct-28-2014
23 Philips Medical Systems, Inc. II Aug-21-2014
24 Siemens Medical Solutions USA, Inc II May-10-2012
25 Spacelabs Healthcare, Incorporated II Aug-25-2010
26 Spacelabs Healthcare, Llc II Mar-25-2014
27 Spacelabs Healthcare, Llc II Jan-17-2013
28 Spacelabs Healthcare, Llc II Jun-20-2012
29 Spacelabs Healthcare, Llc II Jun-22-2011
30 St. Jude Medical II Apr-10-2009

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