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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
Electrical issue 32
Image orientation incorrect 32
Component missing 31
Sensor problems 30
Overheating of device or device component 30
Insulation degradation 27
Failure to interrogate 26
Loose or intermittent connection 26
Computer software issue 23
Defective item 23
Connection error 22
Battery failure 22
Device emits odor 22
Failure to back-up 20
Footswitch failure 20
Computer operating system issue 20
Cable, defective 20
Failure to align 19
Material frayed 19
Output above specifications 19
Collimator design problem 18
Detachment of device component 17
Component(s), worn 16
Output, low 16
Wire(s), breakage of 16
Difficult or delayed activation 16
Device operates differently than expected 16
Other (for use when an appropriate device code cannot be identified) 15
Tears, rips, holes in device, device material 15
Calibration error 15
Measurements, inaccurate 14
Failure to transmit record 12
Interlock(s), failure of 12
Detachment of device or device component 12
Power source issue 12
Battery charger, defective 11
Disconnection 11
Application interface becomes non-functional or program exits abnormally 10
Cable break 10
Circuit breaker tripped 9
Crack 9
Electrical wires, defective 9
Tracking 9
Size incorrect for patient 9
Connection issue 9
Motor failure 8
Leak 8
Heat 7
Erratic display 7
Component falling 7
Spark 7
Cut in material 7
Smoking 7
Unknown (for use when the device problem is not known) 6
Use of Device Issue 6
Incorrect or inadequate test results 6
Low battery 6
Operating system becomes non-functional 6
Intermittent capture 6
Total Device Problems 13102

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

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