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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, x-ray, fluoroscopic, image-intensified
Regulation Description Image-intensified fluoroscopic x-ray system.
Product CodeJAA
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 7
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 3
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 10
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 17
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDIVISION MEDICAL IMAGING, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 2
OEC-DIASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 12
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS
  SUBSTANTIALLY EQUIVALENT 11
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 15
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 2028
Computer failure 1064
Device Issue 902
Failure to power-up 746
Image resolution poor 703
Sticking 638
No display or display failure 555
Failure, intermittent 426
Device inoperable 400
No device output 394
Monitor failure 386
Poor quality image 365
Repair 335
Device stops intermittently 318
Self-activation or keying 233
Blank screen 218
Noise 216
Replace 179
Computer hardware error 157
Malfunction 155
Incorrect display 148
Device damaged prior to use 147
Image display error 146
Loss of power 139
Defective component 138
Loose 116
Component(s), broken 106
Arcing 103
Locking mechanism failure 91
Patient Data Issue 89
Output, high 75
Alarm, audible 69
Artifact 66
System fails to activate 61
Loss of Data 59
Failure to charge 46
Break 42
Failure to read input signal 40
Unintended system motion 37
Device remains activated 36
Burn of device or device component 35
Image orientation incorrect 32
Electrical issue 32
Component missing 31
Overheating of device or device component 30
Sensor problems 30
Insulation degradation 27
Loose or intermittent connection 26
Failure to interrogate 26
Computer software issue 23
Defective item 23
Connection error 22
Device emits odor 22
Battery failure 22
Cable, defective 20
Footswitch failure 20
Computer operating system issue 20
Failure to back-up 20
Failure to align 19
Output above specifications 19
Material frayed 19
Collimator design problem 18
Detachment of device component 18
Wire(s), breakage of 16
Component(s), worn 16
Difficult or delayed activation 16
Output, low 16
Device operates differently than expected 16
Tears, rips, holes in device, device material 15
Calibration error 15
Other (for use when an appropriate device code cannot be identified) 15
Measurements, inaccurate 14
Detachment of device or device component 12
Power source issue 12
Failure to transmit record 12
Interlock(s), failure of 12
Disconnection 11
Battery charger, defective 11
Cable break 10
Application interface becomes non-functional or program exits abnormally 10
Circuit breaker tripped 9
Tracking 9
Connection issue 9
Electrical wires, defective 9
Size incorrect for patient 9
Crack 9
Component falling 8
Leak 8
Motor failure 8
Spark 7
Heat 7
Smoking 7
Erratic display 7
Cut in material 7
Incorrect or inadequate test results 6
Mechanical issue 6
Fluid leak 6
Low battery 6
Intermittent capture 6
Use of Incorrect Control Settings 6
Total Device Problems 13104

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 1 0 0 0 0 0
Class II 7 14 10 4 5 11 6 3 4 5 1
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-02-2015
3 GE Healthcare II Sep-19-2008
4 GE Healthcare II Sep-19-2008
5 GE Healthcare II Sep-19-2008
6 GE Healthcare II Sep-18-2008
7 GE Healthcare II Sep-04-2008
8 GE Healthcare II Aug-24-2008
9 GE Healthcare II Aug-02-2008
10 GE Healthcare, LLC II Dec-23-2016
11 GE Healthcare, LLC II Oct-02-2014
12 GE Healthcare, LLC II Jan-21-2014
13 GE Healthcare, LLC II Oct-17-2013
14 GE Healthcare, LLC II Aug-20-2013
15 GE Healthcare, LLC II May-06-2011
16 GE Medical Systems, LLC II Nov-09-2009
17 GE OEC Medical Systems, Inc II Aug-22-2012
18 GE OEC Medical Systems, Inc II Aug-17-2012
19 GE OEC Medical Systems, Inc II Aug-01-2012
20 GE OEC Medical Systems, Inc I Jul-24-2012
21 GE OEC Medical Systems, Inc II Jul-18-2012
22 GE OEC Medical Systems, Inc II Jun-22-2012
23 GE OEC Medical Systems, Inc II Mar-15-2008
24 GE OEC Medical Systems, Inc II Sep-28-2007
25 GE OEC Medical Systems, Inc II Jul-12-2007
26 GE OEC Medical Systems, Inc II Jun-30-2007
27 GE OEC Medical Systems, Inc II Mar-22-2007
28 GE OEC Medical Systems, Inc II Feb-15-2007
29 Ge Healthcare II Jan-20-2010
30 Ge Healthcare II Sep-24-2009
31 Hologic, Inc. II May-17-2013
32 Hologic, Inc. II Sep-25-2012
33 Hologic, Inc. II Aug-12-2011
34 Medtronic Navigation, Inc. II Sep-26-2008
35 NRT - Nordisk Rontgen Teknik A/S II Sep-29-2009
36 OEC Medical Systems, Inc II Jan-05-2009
37 OEC Medical Systems, Inc II Sep-29-2008
38 OEC Medical Systems, Inc II Sep-25-2008
39 OEC Medical Systems, Inc II Sep-20-2008
40 OEC Medical Systems, Inc II Sep-01-2008
41 OEC Medical Systems, Inc II Jul-03-2007
42 Philips Healthcare Inc. II Mar-16-2012
43 Philips Healthcare Inc. II Oct-27-2011
44 Philips Healthcare Inc. II Jul-08-2011
45 Philips Medical Systems Gmbh, DMC II Mar-23-2012
46 Philips Medical Systems North America Co. Phillips II Oct-25-2010
47 Philips Medical Systems North America Co. Phillips II Sep-22-2010
48 Philips Medical Systems North America Co. Phillips II Sep-24-2009
49 Philips Medical Systems North America Co. Phillips II Sep-24-2009
50 Philips Medical Systems North America Co. Phillips II Jan-26-2009
51 Philips Medical Systems North America Co. Phillips II May-28-2008
52 Philips Medical Systems North America Co. Phillips II Nov-10-2007
53 Shimadzu Medical Systems II Dec-23-2016
54 Shimadzu Medical Systems II Nov-09-2015
55 Siemens Medical Solutions USA, Inc II Mar-31-2016
56 Siemens Medical Solutions USA, Inc II May-23-2015
57 Siemens Medical Solutions USA, Inc II Sep-10-2014
58 Siemens Medical Solutions USA, Inc II Nov-27-2013
59 Siemens Medical Solutions USA, Inc II Apr-11-2013
60 Siemens Medical Solutions USA, Inc II Sep-10-2012
61 Siemens Medical Solutions USA, Inc II Jan-27-2012
62 Siemens Medical Solutions USA, Inc II Mar-27-2010
63 Siemens Medical Solutions USA, Inc II Nov-12-2009
64 Siemens Medical Solutions USA, Inc II Jun-16-2009
65 Siemens Medical Solutions USA, Inc II May-06-2009
66 Toshiba American Medical Systems Inc II Jan-12-2017
67 Toshiba American Medical Systems Inc II Mar-21-2016
68 Toshiba American Medical Systems Inc II Jul-10-2013
69 Toshiba American Medical Systems Inc II Apr-15-2011
70 Ziehm Imaging Inc II Aug-25-2016
71 Ziehm Imaging Inc II Apr-16-2012

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