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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, tomography, computed
Regulation Description Computed tomography x-ray system.
Product CodeJAK
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CAS INNOVATIONS AG
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 102
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 10
KULZER
  SUBSTANTIALLY EQUIVALENT 1
MARCONI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 31
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHAERER MAYFIELD
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 90
SUPERDIMENSION, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 62
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Device operates differently than expected 123
Unknown (for use when the device problem is not known) 94
Mechanical issue 89
No Known Device Problem 63
Unintended system motion 42
Detachment of device or device component 31
Artifact 29
Detachment of device component 22
Unintended movement 22
Use of Device Issue 18
Positioning Issue 13
No Information 11
Device displays error message 11
Improper or incorrect procedure or method 10
Output issue 10
Mechanical jam 9
Incorrect or inadequate result 9
Defective component 8
Computer software issue 8
Normal 8
Leak 7
Calibration issue 7
Sticking 6
Electrical issue 6
No display or display failure 5
Component falling 5
Break 5
Loose or intermittent connection 5
Device stops intermittently 5
Slippage of device or device component 5
Application network issue 5
Data Issue 5
Patient Data Issue 4
Improper device output 4
Poor quality image 4
Disconnection 4
Fire 3
Device emits odor 3
Unintended collision 3
Incorrect or inadequate test results 3
Battery issue 3
Self-activation or keying 3
Deployment issue 2
Difficult to advance 2
Malposition of device 2
Loss of power 2
Output above specifications 2
Failure, intermittent 2
Incorrect measurement 2
Computer hardware error 2
Component(s), broken 2
Mechanics altered 2
Human-Device Interface Issue 2
Temperature issue 2
Power source issue 2
Programming issue 2
Device handling issue 2
Noise, Audible 2
Not Applicable 2
Radiation Overexposure 1
Operating system becomes non-functional 1
Inadequate user interface 1
Installation-related problem 1
Material integrity issue 1
Material twisted 1
Device alarm system issue 1
Burn of device or device component 1
Charred 1
Image display error 1
Fail-safe design failure 1
Erratic display 1
Incorrect display 1
Image reversal 1
Device abrasion from instrument or another object 1
Overheating of device or device component 1
Difficult to position 1
Power Conditioning Issue 1
Failure to power-up 1
Premature deployment 1
Patient-device incompatibility 1
Application program issue 1
Computer operating system issue 1
Dislodged or dislocated 1
Environmental control or utility issue 1
Gas leak 1
Device sensing issue 1
Sensor problems 1
Retraction problem 1
Tears, rips, holes in device, device material 1
Inadequate training 1
Smoking 1
Metal shedding debris 1
Component missing 1
Device Issue 1
Malfunction 1
Total Device Problems 800

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 10 5 18 11 25 26 26 23 33 12
Class III 0 1 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardiomedics Incorporated II Jul-07-2009
2 GE Healthcare II Sep-21-2015
3 GE Healthcare II May-15-2015
4 GE Healthcare II Jan-26-2015
5 GE Healthcare II Jan-15-2015
6 GE Healthcare II May-15-2007
7 GE Healthcare II Feb-15-2007
8 GE Healthcare, LLC II Mar-20-2014
9 GE Healthcare, LLC II Mar-06-2014
10 GE Healthcare, LLC II Jan-27-2014
11 GE Healthcare, LLC II Oct-17-2013
12 GE Healthcare, LLC II Aug-09-2013
13 GE Healthcare, LLC II Jun-18-2013
14 GE Healthcare, LLC II Apr-29-2013
15 GE Healthcare, LLC II Mar-01-2013
16 GE Healthcare, LLC II May-19-2011
17 GE Healthcare, LLC II Mar-01-2011
18 GE Healthcare, LLC II Feb-07-2011
19 GE Healthcare, LLC II Jan-04-2011
20 GE Healthcare, LLC II Nov-15-2010
21 GE Medical Systems, LLC II Apr-29-2016
22 GE Medical Systems, LLC II Mar-04-2016
23 GE Medical Systems, LLC II Dec-10-2015
24 GE Medical Systems, LLC II Dec-17-2010
25 GE Medical Systems, LLC II Jan-21-2010
26 GE Medical Systems, LLC II Sep-25-2009
27 GE Medical Systems, LLC II Sep-18-2009
28 GE Medical Systems, LLC II Aug-13-2009
29 Ge Healthcare II Feb-02-2010
30 Hitachi Medical Systems America Inc II Jul-19-2012
31 Hitachi Medical Systems America Inc II Jul-07-2009
32 Hitachi Medical Systems America Inc II Jan-08-2009
33 Imaging Sciences International, LLC II Aug-12-2011
34 Imaging Sciences International, LLC II Dec-17-2009
35 Imaging Sciences Intl Inc II Sep-01-2008
36 Mobius Imaging, LLC II Jan-27-2015
37 Neuisys, LLC II Aug-19-2010
38 Neusoft Medical System Co II Jun-16-2015
39 Neusoft Medical Systems Co., Ltd. II May-11-2016
40 Philips And Neusoft Medical Systems Co., Ltd. II Apr-23-2013
41 Philips And Neusoft Medical Systems Co., Ltd. II Dec-04-2012
42 Philips And Neusoft Medical Systems Co., Ltd. II Jul-26-2012
43 Philips And Neusoft Medical Systems Co., Ltd. II May-23-2011
44 Philips And Neusoft Medical Systems Co., Ltd. II Jan-04-2011
45 Philips And Neusoft Medical Systems Co., Ltd. II Sep-17-2008
46 Philips And Neusoft Medical Systems Co., Ltd. II Sep-17-2008
47 Philips Electronics North America Corporation II Dec-12-2015
48 Philips Healthcare Inc. II Apr-17-2013
49 Philips Healthcare Inc. II Dec-14-2010
50 Philips Medical Systems II Mar-04-2011
51 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
52 Philips Medical Systems (Cleveland) Inc II Apr-08-2016
53 Philips Medical Systems (Cleveland) Inc II Dec-24-2015
54 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
55 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
56 Philips Medical Systems (Cleveland) Inc II Nov-02-2015
57 Philips Medical Systems (Cleveland) Inc II Oct-30-2015
58 Philips Medical Systems (Cleveland) Inc II Jul-24-2015
59 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
60 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
61 Philips Medical Systems (Cleveland) Inc II May-29-2015
62 Philips Medical Systems (Cleveland) Inc II May-22-2015
63 Philips Medical Systems (Cleveland) Inc II Apr-01-2015
64 Philips Medical Systems (Cleveland) Inc II Jan-15-2015
65 Philips Medical Systems (Cleveland) Inc II Dec-16-2014
66 Philips Medical Systems (Cleveland) Inc II Dec-01-2014
67 Philips Medical Systems (Cleveland) Inc II Sep-29-2014
68 Philips Medical Systems (Cleveland) Inc II Sep-26-2014
69 Philips Medical Systems (Cleveland) Inc II Sep-18-2014
70 Philips Medical Systems (Cleveland) Inc II Sep-18-2014
71 Philips Medical Systems (Cleveland) Inc II Aug-14-2014
72 Philips Medical Systems (Cleveland) Inc II Jun-22-2014
73 Philips Medical Systems (Cleveland) Inc II Jun-04-2014
74 Philips Medical Systems (Cleveland) Inc II Apr-16-2014
75 Philips Medical Systems (Cleveland) Inc II Jan-29-2014
76 Philips Medical Systems (Cleveland) Inc II Jan-27-2014
77 Philips Medical Systems (Cleveland) Inc II Jan-27-2014
78 Philips Medical Systems (Cleveland) Inc II Jan-21-2014
79 Philips Medical Systems (Cleveland) Inc II Nov-15-2013
80 Philips Medical Systems (Cleveland) Inc II Oct-17-2013
81 Philips Medical Systems (Cleveland) Inc II Oct-17-2013
82 Philips Medical Systems (Cleveland) Inc II Sep-16-2013
83 Philips Medical Systems (Cleveland) Inc II Jul-02-2013
84 Philips Medical Systems (Cleveland) Inc II Jun-25-2013
85 Philips Medical Systems (Cleveland) Inc II May-20-2013
86 Philips Medical Systems (Cleveland) Inc II Apr-12-2013
87 Philips Medical Systems (Cleveland) Inc II Mar-14-2013
88 Philips Medical Systems (Cleveland) Inc II Mar-13-2013
89 Philips Medical Systems (Cleveland) Inc II Mar-05-2013
90 Philips Medical Systems (Cleveland) Inc II Feb-28-2013
91 Philips Medical Systems (Cleveland) Inc II Feb-26-2013
92 Philips Medical Systems (Cleveland) Inc II Feb-26-2013
93 Philips Medical Systems (Cleveland) Inc II Jan-16-2013
94 Philips Medical Systems (Cleveland) Inc II Jan-15-2013
95 Philips Medical Systems (Cleveland) Inc II Sep-25-2012
96 Philips Medical Systems (Cleveland) Inc III Sep-19-2012
97 Philips Medical Systems (Cleveland) Inc II Sep-14-2012
98 Philips Medical Systems (Cleveland) Inc II Aug-22-2012
99 Philips Medical Systems (Cleveland) Inc II Aug-17-2012
100 Philips Medical Systems (Cleveland) Inc II Jul-19-2012
101 Philips Medical Systems (Cleveland) Inc II Jul-12-2012
102 Philips Medical Systems (Cleveland) Inc II Jul-11-2012
103 Philips Medical Systems (Cleveland) Inc II Jul-11-2012
104 Philips Medical Systems (Cleveland) Inc II Jun-08-2012
105 Philips Medical Systems (Cleveland) Inc II May-30-2012
106 Philips Medical Systems (Cleveland) Inc II May-30-2012
107 Philips Medical Systems (Cleveland) Inc II Apr-05-2012
108 Philips Medical Systems (Cleveland) Inc II Apr-02-2012
109 Philips Medical Systems (Cleveland) Inc II Mar-23-2012
110 Philips Medical Systems (Cleveland) Inc II Feb-16-2012
111 Philips Medical Systems (Cleveland) Inc II Feb-03-2012
112 Philips Medical Systems (Cleveland) Inc II Jan-24-2012
113 Philips Medical Systems (Cleveland) Inc II Jan-17-2012
114 Philips Medical Systems (Cleveland) Inc II Jan-11-2012
115 Philips Medical Systems (Cleveland) Inc II Dec-02-2011
116 Philips Medical Systems (Cleveland) Inc II Dec-01-2011
117 Philips Medical Systems (Cleveland) Inc II Sep-27-2011
118 Philips Medical Systems (Cleveland) Inc II Sep-14-2011
119 Philips Medical Systems (Cleveland) Inc II Sep-13-2011
120 Philips Medical Systems (Cleveland) Inc II May-19-2011
121 Philips Medical Systems (Cleveland) Inc II Apr-26-2011
122 Philips Medical Systems (Cleveland) Inc II Mar-24-2011
123 Philips Medical Systems (Cleveland) Inc II Oct-22-2010
124 Philips Medical Systems (Cleveland) Inc II Sep-22-2010
125 Philips Medical Systems (Cleveland) Inc II Nov-17-2009
126 Philips Medical Systems (Cleveland) Inc II Nov-13-2009
127 Philips Medical Systems (Cleveland) Inc II Jul-13-2009
128 Philips Medical Systems (Cleveland) Inc II Jul-06-2009
129 Philips Medical Systems (Cleveland) Inc II Jun-29-2009
130 Philips Medical Systems (Cleveland) Inc II Dec-29-2007
131 Philips Medical Systems (Cleveland) Inc II Nov-21-2007
132 Philips Medical Systems (Cleveland) Inc II Nov-07-2007
133 Philips Medical Systems (Cleveland) Inc II Oct-31-2007
134 Philips Medical Systems (Cleveland) Inc II Sep-13-2007
135 Philips Medical Systems North America Co. Phillips II Jul-09-2011
136 Philips Medical Systems North America Co. Phillips II May-19-2011
137 Philips Medical Systems, Inc. II Dec-16-2014
138 Philips and Neusoft Medical Systems Co., Ltd. II Apr-27-2016
139 Siemens Medical Solutions USA, Inc II Apr-22-2016
140 Siemens Medical Solutions USA, Inc II Apr-19-2016
141 Siemens Medical Solutions USA, Inc II Apr-08-2016
142 Siemens Medical Solutions USA, Inc II Mar-31-2016
143 Siemens Medical Solutions USA, Inc II Oct-06-2015
144 Siemens Medical Solutions USA, Inc II Oct-05-2015
145 Siemens Medical Solutions USA, Inc II Jun-27-2015
146 Siemens Medical Solutions USA, Inc II May-22-2015
147 Siemens Medical Solutions USA, Inc II Mar-12-2015
148 Siemens Medical Solutions USA, Inc II Jan-14-2015
149 Siemens Medical Solutions USA, Inc II Jun-04-2014
150 Siemens Medical Solutions USA, Inc II Feb-03-2014
151 Siemens Medical Solutions USA, Inc II Mar-14-2013
152 Siemens Medical Solutions USA, Inc II Jul-30-2009
153 Siemens Medical Solutions USA, Inc II Jun-16-2009
154 Siemens Medical Solutions USA, Inc II Jan-23-2009
155 Siemens Medical Solutions USA, Inc II Jan-05-2009
156 Siemens Medical Solutions USA, Inc II Sep-21-2008
157 Siemens Medical Solutions USA, Inc. II Jan-21-2016
158 Siemens Medical Solutions USA, Inc. II Nov-23-2011
159 Siemens Medical Solutions USA, Inc. II Dec-29-2009
160 Siemens Medical Solutions USA, Inc. II Feb-23-2007
161 SuperDimension, Inc. II Mar-29-2007
162 Toshiba American Med Sys Inc II Sep-29-2008
163 Toshiba American Medical Systems Inc II Apr-22-2016
164 Toshiba American Medical Systems Inc II Oct-09-2015
165 Toshiba American Medical Systems Inc II Nov-26-2014
166 Toshiba American Medical Systems Inc II Mar-06-2014
167 Toshiba American Medical Systems Inc II Mar-03-2014
168 Toshiba American Medical Systems Inc II Apr-08-2013
169 Toshiba American Medical Systems Inc II Apr-08-2013
170 Toshiba American Medical Systems Inc II Sep-27-2012
171 Toshiba American Medical Systems Inc II Aug-28-2012
172 Toshiba American Medical Systems Inc II Aug-24-2012
173 Toshiba American Medical Systems Inc II Feb-15-2012
174 Toshiba American Medical Systems Inc II Sep-16-2011
175 Toshiba American Medical Systems Inc II Sep-13-2011
176 Toshiba American Medical Systems Inc II Jul-29-2011
177 Toshiba American Medical Systems Inc II May-19-2011
178 Toshiba American Medical Systems Inc II Mar-16-2011
179 Toshiba American Medical Systems Inc II Feb-15-2011
180 Toshiba American Medical Systems Inc II Sep-01-2010
181 Toshiba American Medical Systems Inc II Mar-19-2010
182 Toshiba American Medical Systems Inc II Mar-02-2010
183 Xoran Technologies, Inc. II Jun-26-2015
184 Xoran Technologies, Inc. II Jun-26-2015
185 Xoran Technologies, Inc. II Jun-26-2015
186 Xoran Technologies, Inc. II Jun-26-2015
187 Xoran Technologies, Inc. II Jun-26-2015
188 Xoran Technologies, Inc. II Dec-23-2009
189 Xoran Technologies, Inc. III Feb-07-2008
190 Xoran Technologies, Inc. II Nov-27-2007
191 Xoran Technologies, LLC II Mar-02-2015

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