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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device interventional fluoroscopic x-ray system
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Interventional fluoroscopy
Product CodeOWB
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 32
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 18
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 12
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 1686
Device displays error message 878
Device stops intermittently 796
Failure to power-up 293
Application interface becomes non-functional or program exits abnormally 179
Loss of Data 135
Patient Data Issue 67
Loss of power 54
Communication or transmission issue 24
Device operates differently than expected 22
Device remains activated 22
Arcing 18
Computer operating system issue 18
Detachment of device or device component 14
Detachment of device component 13
Unintended movement 10
Electrical issue 9
No Known Device Problem 7
Mechanical jam 5
Mechanical issue 5
Incorrect display 5
Component falling 4
Power source issue 4
Radiation Overexposure 3
Electrical shorting 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Defective component 2
Unintended system motion 2
Computer software issue 2
Intermittent continuity 2
Bent 2
Poor quality image 2
No display or display failure 2
Calibration issue 2
Material deformation 2
No Information 2
No code available 2
Data Issue 2
Improper device output 1
Manufacturing or shipping issue associated with device 1
Connection issue 1
Device sensing issue 1
Difficult to open or close 1
Dislodged or dislocated 1
Electrical power problem 1
Device handling issue 1
Noise, Audible 1
Failure to run on AC/DC 1
Unintended energization 1
Device emits odor 1
Fire 1
Biofilm coating in device 1
Break 1
Burn of device or device component 1
Circuit Failure 1
Continuous firing 1
Overheating of device or device component 1
Plunge 1
Failure to advance 1
Inappropriate shock 1
Spark 1
Failure to fire 1
Ambient temperature issue 1
Application program issue 1
Total Device Problems 4330

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 0 0 0 0 0 0 9 10 15 11
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Jul-20-2015
2 GE Healthcare II Jul-03-2015
3 GE Healthcare II Jan-14-2015
4 GE Healthcare, LLC II Dec-16-2014
5 GE Healthcare, LLC II Mar-10-2014
6 GE Healthcare, LLC II Feb-03-2014
7 GE Healthcare, LLC II Oct-17-2013
8 GE Healthcare, LLC II Sep-18-2013
9 GE Healthcare, LLC II Jun-28-2013
10 GE Healthcare, LLC II May-14-2013
11 GE Healthcare, LLC II Apr-18-2013
12 GE Medical Systems, LLC II Feb-05-2016
13 GE OEC Medical Systems, Inc II Nov-07-2014
14 GE OEC Medical Systems, Inc II Apr-16-2014
15 Leibel-Flarsheim Company LLC II Jul-18-2013
16 Medtronic Navigation, Inc. II Mar-08-2016
17 Philips Electronics North America Corporation II Mar-07-2016
18 Philips Electronics North America Corporation II Feb-05-2016
19 Philips Electronics North America Corporation II Jan-30-2016
20 Philips Medical Systems, Inc. II Dec-01-2015
21 Philips Medical Systems, Inc. II Nov-07-2014
22 Philips Medical Systems, Inc. II Oct-09-2014
23 Regulatory Insight, Inc II Feb-24-2016
24 Siemens Medical Solutions USA, Inc II Mar-31-2016
25 Siemens Medical Solutions USA, Inc II Mar-31-2016
26 Siemens Medical Solutions USA, Inc II Mar-31-2016
27 Siemens Medical Solutions USA, Inc II Mar-31-2016
28 Siemens Medical Solutions USA, Inc II Dec-24-2015
29 Siemens Medical Solutions USA, Inc II Oct-23-2015
30 Siemens Medical Solutions USA, Inc II Aug-18-2015
31 Siemens Medical Solutions USA, Inc II Aug-05-2015
32 Siemens Medical Solutions USA, Inc II Jul-02-2015
33 Siemens Medical Solutions USA, Inc II Jun-25-2015
34 Siemens Medical Solutions USA, Inc II May-23-2015
35 Siemens Medical Solutions USA, Inc II Apr-14-2015
36 Siemens Medical Solutions USA, Inc II Feb-17-2015
37 Siemens Medical Solutions USA, Inc II Jan-14-2015
38 Siemens Medical Solutions USA, Inc II Sep-16-2014
39 Siemens Medical Solutions USA, Inc II Jun-04-2014
40 Siemens Medical Solutions USA, Inc II Mar-27-2014
41 Siemens Medical Solutions USA, Inc II Nov-01-2013
42 Siemens Medical Solutions USA, Inc II Aug-01-2013
43 Toshiba American Medical Systems Inc II Feb-09-2016
44 Toshiba American Medical Systems Inc II Apr-06-2015
45 Ziehm Imaging Inc II Dec-24-2013

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