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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 3
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 2476
Device stops intermittently 1114
Device displays error message 1088
Failure to power-up 347
Application interface becomes non-functional or program exits abnormally 244
Loss of Data 181
Patient Data Issue 82
Loss of power 72
Device operates differently than expected 51
Electrical issue 42
Device remains activated 37
Communication or transmission issue 34
Arcing 27
Detachment of device component 27
Detachment of device or device component 21
Computer operating system issue 18
Unintended movement 11
Computer software issue 11
Mechanical issue 9
No Known Device Problem 7
Difficult to open or close 6
No display or display failure 6
Incorrect display 6
Mechanical jam 5
Calibration issue 5
Electrical shorting 4
Power source issue 4
Component falling 4
Radiation Overexposure 3
Failure to fire 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Defective component 2
No Information 2
No code available 2
Data Issue 2
Material deformation 2
Intermittent continuity 2
Bent 2
Calibration error 2
Grounding malfunction 2
Imprecision 2
Poor quality image 2
Device emits odor 2
Unintended system motion 2
No device output 2
Overheating of device or device component 1
Plunge 1
Power Conditioning Issue 1
Image reversal 1
Inappropriate shock 1
Fire 1
Circuit Failure 1
Failure to run on AC/DC 1
Unintended arm motion 1
Biofilm coating in device 1
Break 1
Burn of device or device component 1
Continuous firing 1
Insufficient cooling 1
Unintended energization 1
Improper device output 1
Manufacturing or shipping issue associated with device 1
Dislodged or dislocated 1
Electrical power problem 1
Device sensing issue 1
Device handling issue 1
Noise, Audible 1
Failure to advance 1
Spark 1
Ambient temperature issue 1
Application program issue 1
Connection issue 1
Total Device Problems 6006

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 17
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 May-23-2016
13 GE Medical Systems, LLC II Feb-05-2016
14 GE OEC Medical Systems, Inc II Aug-23-2016
15 GE OEC Medical Systems, Inc II Nov-07-2014
16 GE OEC Medical Systems, Inc II Apr-16-2014
17 Leibel-Flarsheim Company LLC II Jul-18-2013
18 Medtronic Navigation, Inc. II Mar-08-2016
19 Medtronic Navigation, Inc.-Littleton II Jul-06-2016
20 Philips Electronics North America Corporation II Aug-26-2016
21 Philips Electronics North America Corporation II Mar-07-2016
22 Philips Electronics North America Corporation II Feb-05-2016
23 Philips Electronics North America Corporation II Jan-30-2016
24 Philips Medical Systems, Inc. II Dec-01-2015
25 Philips Medical Systems, Inc. II Nov-07-2014
26 Philips Medical Systems, Inc. II Oct-09-2014
27 Regulatory Insight, Inc II Feb-24-2016
28 Siemens Medical Solutions USA, Inc II Mar-31-2016
29 Siemens Medical Solutions USA, Inc II Mar-31-2016
30 Siemens Medical Solutions USA, Inc II Mar-31-2016
31 Siemens Medical Solutions USA, Inc II Mar-31-2016
32 Siemens Medical Solutions USA, Inc II Dec-24-2015
33 Siemens Medical Solutions USA, Inc II Oct-23-2015
34 Siemens Medical Solutions USA, Inc II Aug-18-2015
35 Siemens Medical Solutions USA, Inc II Aug-05-2015
36 Siemens Medical Solutions USA, Inc II Jul-02-2015
37 Siemens Medical Solutions USA, Inc II Jun-25-2015
38 Siemens Medical Solutions USA, Inc II May-23-2015
39 Siemens Medical Solutions USA, Inc II Apr-14-2015
40 Siemens Medical Solutions USA, Inc II Feb-17-2015
41 Siemens Medical Solutions USA, Inc II Jan-14-2015
42 Siemens Medical Solutions USA, Inc II Sep-16-2014
43 Siemens Medical Solutions USA, Inc II Jun-04-2014
44 Siemens Medical Solutions USA, Inc II Mar-27-2014
45 Siemens Medical Solutions USA, Inc II Nov-01-2013
46 Siemens Medical Solutions USA, Inc II Aug-01-2013
47 Toshiba American Medical Systems Inc II Jul-18-2016
48 Toshiba American Medical Systems Inc II Feb-09-2016
49 Toshiba American Medical Systems Inc II Apr-06-2015
50 Ziehm Imaging Inc II Aug-25-2016
51 Ziehm Imaging Inc II Dec-24-2013

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