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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 13
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 3607
Device stops intermittently 1645
Device displays error message 1397
Failure to power-up 428
Application interface becomes non-functional or program exits abnormally 337
Device operates differently than expected 330
Loss of Data 259
Electrical issue 152
Patient Data Issue 105
Loss of power 93
Difficult to open or close 71
Communication or transmission issue 70
Computer software issue 62
Device remains activated 48
Calibration issue 43
Arcing 36
Mechanical issue 30
Detachment of device component 28
Incorrect display 23
Detachment of device or device component 23
Computer operating system issue 18
Unintended movement 14
Material deformation 10
No Known Device Problem 7
No display or display failure 7
Imprecision 7
Poor quality image 7
Mechanical jam 6
Failure to fire 5
Use of Device Issue 5
Electrical shorting 4
Component falling 4
Calibration error 4
Power source issue 4
Radiation Overexposure 3
Data Issue 3
Circuit Failure 3
Intermittent continuity 3
Device emits odor 3
No device output 3
Improper or incorrect procedure or method 3
Defective component 2
Grounding malfunction 2
Spark 2
Positioning Issue 2
Unintended system motion 2
Break 2
Bent 2
Device handling issue 2
No Information 2
No code available 2
Noise, Audible 1
Biofilm coating in device 1
Failure to run on AC/DC 1
Unintended arm motion 1
Burn of device or device component 1
Continuous firing 1
Insufficient cooling 1
Unintended energization 1
Overheating of device or device component 1
Plunge 1
Power Conditioning Issue 1
Image reversal 1
Loose or intermittent connection 1
Device maintenance issue 1
Fire 1
Improper device output 1
Maintenance does not comply to manufacturers recommendations 1
Manufacturing or shipping issue associated with device 1
Connection issue 1
Dislodged or dislocated 1
Electrical power problem 1
Device sensing issue 1
Inadequate training 1
Ambient temperature issue 1
Application program issue 1
Inappropriate shock 1
Failure to advance 1
Total Device Problems 8957

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 0 0 0 0 0 0 9 10 15 20 7
Class III 0 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-23-2016
5 GE Healthcare, LLC II Dec-16-2014
6 GE Healthcare, LLC II Mar-10-2014
7 GE Healthcare, LLC II Feb-03-2014
8 GE Healthcare, LLC II Oct-17-2013
9 GE Healthcare, LLC II Sep-18-2013
10 GE Healthcare, LLC II Jun-28-2013
11 GE Healthcare, LLC II May-14-2013
12 GE Healthcare, LLC II Apr-18-2013
13 GE Medical Systems, LLC II May-23-2016
14 GE Medical Systems, LLC II Feb-05-2016
15 GE OEC Medical Systems, Inc II Jan-20-2017
16 GE OEC Medical Systems, Inc II Jan-09-2017
17 GE OEC Medical Systems, Inc II Aug-23-2016
18 GE OEC Medical Systems, Inc II Nov-07-2014
19 GE OEC Medical Systems, Inc II Apr-16-2014
20 Leibel-Flarsheim Company LLC II Jul-18-2013
21 Medtronic Navigation, Inc. II Mar-08-2016
22 Medtronic Navigation, Inc.-Littleton II Oct-11-2016
23 Medtronic Navigation, Inc.-Littleton II Jul-06-2016
24 Philips Electronics North America Corporation II Apr-14-2017
25 Philips Electronics North America Corporation II Jan-20-2017
26 Philips Electronics North America Corporation II Aug-26-2016
27 Philips Electronics North America Corporation II Mar-07-2016
28 Philips Electronics North America Corporation II Feb-05-2016
29 Philips Electronics North America Corporation II Jan-30-2016
30 Philips Medical Systems, Inc. II Dec-01-2015
31 Philips Medical Systems, Inc. II Nov-07-2014
32 Philips Medical Systems, Inc. II Oct-09-2014
33 Regulatory Insight, Inc II Feb-24-2016
34 Siemens Medical Solutions USA, Inc II Mar-19-2017
35 Siemens Medical Solutions USA, Inc II Mar-14-2017
36 Siemens Medical Solutions USA, Inc II Jan-09-2017
37 Siemens Medical Solutions USA, Inc II Nov-17-2016
38 Siemens Medical Solutions USA, Inc II Mar-31-2016
39 Siemens Medical Solutions USA, Inc II Mar-31-2016
40 Siemens Medical Solutions USA, Inc II Mar-31-2016
41 Siemens Medical Solutions USA, Inc II Mar-31-2016
42 Siemens Medical Solutions USA, Inc II Dec-24-2015
43 Siemens Medical Solutions USA, Inc II Oct-23-2015
44 Siemens Medical Solutions USA, Inc II Aug-18-2015
45 Siemens Medical Solutions USA, Inc II Aug-05-2015
46 Siemens Medical Solutions USA, Inc II Jul-02-2015
47 Siemens Medical Solutions USA, Inc II Jun-25-2015
48 Siemens Medical Solutions USA, Inc II May-23-2015
49 Siemens Medical Solutions USA, Inc II Apr-14-2015
50 Siemens Medical Solutions USA, Inc II Feb-17-2015
51 Siemens Medical Solutions USA, Inc II Jan-14-2015
52 Siemens Medical Solutions USA, Inc II Sep-16-2014
53 Siemens Medical Solutions USA, Inc II Jun-04-2014
54 Siemens Medical Solutions USA, Inc II Mar-27-2014
55 Siemens Medical Solutions USA, Inc II Nov-01-2013
56 Siemens Medical Solutions USA, Inc II Aug-01-2013
57 Toshiba American Medical Systems Inc II Jul-18-2016
58 Toshiba American Medical Systems Inc II Feb-09-2016
59 Toshiba American Medical Systems Inc II Apr-06-2015
60 Ziehm Imaging Inc II Aug-25-2016
61 Ziehm Imaging Inc II Dec-24-2013

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