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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 2207
Device displays error message 1018
Device stops intermittently 1000
Failure to power-up 334
Application interface becomes non-functional or program exits abnormally 217
Loss of Data 165
Patient Data Issue 78
Loss of power 66
Device operates differently than expected 45
Device remains activated 33
Communication or transmission issue 32
Electrical issue 31
Arcing 24
Detachment of device component 22
Detachment of device or device component 20
Computer operating system issue 18
Unintended movement 11
Computer software issue 10
Mechanical issue 8
No Known Device Problem 7
Incorrect display 6
No display or display failure 5
Mechanical jam 5
Difficult to open or close 4
Power source issue 4
Calibration issue 4
Component falling 4
Failure to fire 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Radiation Overexposure 3
Electrical shorting 3
Material deformation 2
No Information 2
No code available 2
Data Issue 2
Defective component 2
Intermittent continuity 2
Bent 2
Calibration error 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
Grounding malfunction 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
Failure to advance 1
Spark 1
Ambient temperature issue 1
Application program issue 1
Connection issue 1
Device handling issue 1
Noise, Audible 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
Total Device Problems 5447

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

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