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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 3257
Device stops intermittently 1458
Device displays error message 1329
Failure to power-up 412
Application interface becomes non-functional or program exits abnormally 308
Loss of Data 228
Device operates differently than expected 196
Electrical issue 114
Patient Data Issue 98
Loss of power 88
Communication or transmission issue 46
Device remains activated 43
Difficult to open or close 36
Arcing 34
Computer software issue 34
Calibration issue 28
Detachment of device component 27
Detachment of device or device component 23
Mechanical issue 22
Computer operating system issue 18
Incorrect display 15
Unintended movement 11
Material deformation 7
No display or display failure 7
No Known Device Problem 7
Mechanical jam 6
Electrical shorting 4
Poor quality image 4
Imprecision 4
Calibration error 4
Component falling 4
Use of Device Issue 4
Power source issue 4
Data Issue 3
Improper or incorrect procedure or method 3
Failure to fire 3
Radiation Overexposure 3
No device output 3
Device emits odor 3
Break 2
No Information 2
Grounding malfunction 2
Device sensing issue 2
Defective component 2
Spark 2
Bent 2
No code available 2
Unintended system motion 2
Intermittent continuity 2
Circuit Failure 2
Continuous firing 1
Connection issue 1
Biofilm coating in device 1
Unintended energization 1
Electrical power problem 1
Insufficient cooling 1
Dislodged or dislocated 1
Maintenance does not comply to manufacturers recommendations 1
Fire 1
Power Conditioning Issue 1
Inappropriate shock 1
Ambient temperature issue 1
Improper device output 1
Failure to advance 1
Manufacturing or shipping issue associated with device 1
Burn of device or device component 1
Noise, Audible 1
Overheating of device or device component 1
Unintended arm motion 1
Failure to run on AC/DC 1
Plunge 1
Application program issue 1
Image reversal 1
Device handling issue 1
Device maintenance issue 1
Total Device Problems 7945

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 4
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 Jan-20-2017
25 Philips Electronics North America Corporation II Aug-26-2016
26 Philips Electronics North America Corporation II Mar-07-2016
27 Philips Electronics North America Corporation II Feb-05-2016
28 Philips Electronics North America Corporation II Jan-30-2016
29 Philips Medical Systems, Inc. II Dec-01-2015
30 Philips Medical Systems, Inc. II Nov-07-2014
31 Philips Medical Systems, Inc. II Oct-09-2014
32 Regulatory Insight, Inc II Feb-24-2016
33 Siemens Medical Solutions USA, Inc II Jan-09-2017
34 Siemens Medical Solutions USA, Inc II Nov-17-2016
35 Siemens Medical Solutions USA, Inc II Mar-31-2016
36 Siemens Medical Solutions USA, Inc II Mar-31-2016
37 Siemens Medical Solutions USA, Inc II Mar-31-2016
38 Siemens Medical Solutions USA, Inc II Mar-31-2016
39 Siemens Medical Solutions USA, Inc II Dec-24-2015
40 Siemens Medical Solutions USA, Inc II Oct-23-2015
41 Siemens Medical Solutions USA, Inc II Aug-18-2015
42 Siemens Medical Solutions USA, Inc II Aug-05-2015
43 Siemens Medical Solutions USA, Inc II Jul-02-2015
44 Siemens Medical Solutions USA, Inc II Jun-25-2015
45 Siemens Medical Solutions USA, Inc II May-23-2015
46 Siemens Medical Solutions USA, Inc II Apr-14-2015
47 Siemens Medical Solutions USA, Inc II Feb-17-2015
48 Siemens Medical Solutions USA, Inc II Jan-14-2015
49 Siemens Medical Solutions USA, Inc II Sep-16-2014
50 Siemens Medical Solutions USA, Inc II Jun-04-2014
51 Siemens Medical Solutions USA, Inc II Mar-27-2014
52 Siemens Medical Solutions USA, Inc II Nov-01-2013
53 Siemens Medical Solutions USA, Inc II Aug-01-2013
54 Toshiba American Medical Systems Inc II Jul-18-2016
55 Toshiba American Medical Systems Inc II Feb-09-2016
56 Toshiba American Medical Systems Inc II Apr-06-2015
57 Ziehm Imaging Inc II Aug-25-2016
58 Ziehm Imaging Inc II Dec-24-2013

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