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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
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 9
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 18
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Application interface becomes non-functional or program exits abnormally 58
Device Issue 32
Device operates differently than expected 26
Computer software issue 24
Data Issue 22
Application program issue 22
Device displays error message 16
Communication or transmission issue 12
Loss of Data 11
Erratic display 11
Patient Data Issue 10
No display or display failure 9
Failure to pace or properly pace 8
Failure to transmit record 8
Use of Device Issue 7
Failure to cycle 7
No Known Device Problem 7
Connection issue 6
Image display error 5
Disconnection 5
Overheating of device or device component 5
Smoking 4
Device alarm system issue 4
Noise, Audible 4
Blocked connection 3
Artifact 3
Incorrect display 3
Incorrect measurement 2
Break 2
Decoupling 2
Use of Incorrect Control Settings 2
Device stops intermittently 2
Difficult to remove 2
Device emits odor 2
Spark 2
Arcing 2
Computer operating system issue 2
Electronic property issue 2
Improper device output 2
Not Applicable 2
No Information 2
No pacing 1
Operating system version or upgrade problem 1
Output issue 1
Problem with software installation 1
Programming issue 1
Therapeutic or diagnostic output failure 1
Malposition of device 1
Application network issue 1
Calibration issue 1
Failure to obtain samples 1
Oversensing 1
Parameter calculation error due to software problem 1
Difficult to position 1
Failure to power-up 1
Incorrect software programming calculations 1
Radio signal problem 1
Failure to sense 1
Inappropriate shock 1
Failure to select signal 1
Inaccurate synchronization 1
Improper or incorrect procedure or method 1
Low impedance 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
Total Device Problems 389

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 1 2 3 2 4 3 4 6 0
Class III 0 0 0 0 1 0 0 0 0 0

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

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