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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 12
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 35
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHAERER MAYFIELD
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 97
SUPERDIMENSION, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 66
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No Known Device Problem 290
Device operates differently than expected 125
Mechanical issue 95
Unknown (for use when the device problem is not known) 94
Unintended system motion 42
Detachment of device or device component 31
Artifact 29
Detachment of device component 28
Unintended movement 24
Use of Device Issue 21
No Information 13
Positioning Issue 13
Improper or incorrect procedure or method 11
Device displays error message 11
Output issue 10
Mechanical jam 9
Incorrect or inadequate result 9
Defective component 8
Application network issue 8
Computer software issue 8
Normal 8
Leak 8
Calibration issue 7
Sticking 6
Electrical issue 6
No display or display failure 5
Component falling 5
Break 5
Loose or intermittent connection 5
Poor quality image 5
Device stops intermittently 5
Slippage of device or device component 5
Programming issue 5
Material deformation 5
Improper device output 4
Data Issue 4
Patient Data Issue 4
Disconnection 4
Fire 3
Device emits odor 3
Unintended collision 3
Overheating of device or device component 3
Smoking 3
Self-activation or keying 3
Connection issue 3
Incorrect or inadequate test results 3
Battery issue 3
Power source issue 3
Mechanics altered 2
Human-Device Interface Issue 2
Device handling issue 2
Noise, Audible 2
Temperature issue 2
Not Applicable 2
Malposition of device 2
Device Issue 2
Deployment issue 2
Difficult to advance 2
Device inoperable 2
Loss of power 2
Output above specifications 2
Failure, intermittent 2
Incorrect measurement 2
Image display error 2
Computer hardware error 2
Component(s), broken 2
Device alarm system issue 1
Burn of device or device component 1
Charred 1
Circuit Failure 1
Fail-safe design failure 1
Erratic display 1
Incorrect display 1
Electro-magnetic interference (EMI) 1
Image reversal 1
Device abrasion from instrument or another object 1
Failure to power-up 1
Premature deployment 1
Difficult to position 1
Power Conditioning Issue 1
Component missing 1
Metal shedding debris 1
Sensor problems 1
Retraction problem 1
Tears, rips, holes in device, device material 1
Inadequate training 1
Dislodged or dislocated 1
Environmental control or utility issue 1
Gas leak 1
Computer operating system issue 1
Malfunction 1
Patient-device incompatibility 1
Application program issue 1
Device sensing issue 1
Inadequate user interface 1
Installation-related problem 1
Material integrity issue 1
Material twisted 1
Operating system becomes non-functional 1
Radiation Overexposure 1
Total Device Problems 1075

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 10 5 18 11 25 26 26 23 33 36 6
Class III 0 1 0 0 0 1 0 0 0 1 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 Jun-12-2017
9 GE Healthcare, LLC II Jun-06-2016
10 GE Healthcare, LLC II Mar-20-2014
11 GE Healthcare, LLC II Mar-06-2014
12 GE Healthcare, LLC II Jan-27-2014
13 GE Healthcare, LLC II Oct-17-2013
14 GE Healthcare, LLC II Aug-09-2013
15 GE Healthcare, LLC II Jun-18-2013
16 GE Healthcare, LLC II Apr-29-2013
17 GE Healthcare, LLC II Mar-01-2013
18 GE Healthcare, LLC II May-19-2011
19 GE Healthcare, LLC II Mar-01-2011
20 GE Healthcare, LLC II Feb-07-2011
21 GE Healthcare, LLC II Jan-04-2011
22 GE Healthcare, LLC II Nov-15-2010
23 GE Medical Systems, LLC II Apr-29-2016
24 GE Medical Systems, LLC II Mar-04-2016
25 GE Medical Systems, LLC II Dec-10-2015
26 GE Medical Systems, LLC II Dec-17-2010
27 GE Medical Systems, LLC II Jan-21-2010
28 GE Medical Systems, LLC II Sep-25-2009
29 GE Medical Systems, LLC II Sep-18-2009
30 GE Medical Systems, LLC II Aug-13-2009
31 Ge Healthcare II Feb-02-2010
32 Hitachi Medical Systems America Inc II Aug-11-2016
33 Hitachi Medical Systems America Inc II Jul-19-2012
34 Hitachi Medical Systems America Inc II Jul-07-2009
35 Hitachi Medical Systems America Inc II Jan-08-2009
36 Imaging Sciences International, LLC II Aug-12-2011
37 Imaging Sciences International, LLC II Dec-17-2009
38 Imaging Sciences Intl Inc II Sep-01-2008
39 Mobius Imaging, LLC II Jan-27-2015
40 Neuisys, LLC II Aug-19-2010
41 Neusoft Medical System Co II Jun-16-2015
42 Neusoft Medical Systems Co., Ltd. II Dec-23-2016
43 Neusoft Medical Systems Co., Ltd. II May-11-2016
44 Northridge Tri-Modality Imaging, II Sep-30-2016
45 Philips And Neusoft Medical Systems Co., Ltd. II Apr-23-2013
46 Philips And Neusoft Medical Systems Co., Ltd. II Dec-04-2012
47 Philips And Neusoft Medical Systems Co., Ltd. II Jul-26-2012
48 Philips And Neusoft Medical Systems Co., Ltd. II May-23-2011
49 Philips And Neusoft Medical Systems Co., Ltd. II Jan-04-2011
50 Philips And Neusoft Medical Systems Co., Ltd. II Sep-17-2008
51 Philips And Neusoft Medical Systems Co., Ltd. II Sep-17-2008
52 Philips Electronics North America Corporation II Nov-22-2016
53 Philips Electronics North America Corporation II Dec-12-2015
54 Philips Healthcare II Jun-06-2016
55 Philips Healthcare Inc. II Apr-17-2013
56 Philips Healthcare Inc. II Dec-14-2010
57 Philips Medical Systems II Mar-04-2011
58 Philips Medical Systems II Oct-04-2016
59 Philips Medical Systems (Cleveland) Inc II Mar-20-2017
60 Philips Medical Systems (Cleveland) Inc II Jan-20-2017
61 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
62 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
63 Philips Medical Systems (Cleveland) Inc II Dec-02-2016
64 Philips Medical Systems (Cleveland) Inc III Nov-16-2016
65 Philips Medical Systems (Cleveland) Inc II Aug-25-2016
66 Philips Medical Systems (Cleveland) Inc II Aug-10-2016
67 Philips Medical Systems (Cleveland) Inc II Aug-09-2016
68 Philips Medical Systems (Cleveland) Inc II Aug-05-2016
69 Philips Medical Systems (Cleveland) Inc II Jul-01-2016
70 Philips Medical Systems (Cleveland) Inc II Jun-30-2016
71 Philips Medical Systems (Cleveland) Inc II Jun-30-2016
72 Philips Medical Systems (Cleveland) Inc II May-31-2016
73 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
74 Philips Medical Systems (Cleveland) Inc II Apr-08-2016
75 Philips Medical Systems (Cleveland) Inc II Dec-24-2015
76 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
77 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
78 Philips Medical Systems (Cleveland) Inc II Nov-02-2015
79 Philips Medical Systems (Cleveland) Inc II Oct-30-2015
80 Philips Medical Systems (Cleveland) Inc II Jul-24-2015
81 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
82 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
83 Philips Medical Systems (Cleveland) Inc II May-29-2015
84 Philips Medical Systems (Cleveland) Inc II May-22-2015
85 Philips Medical Systems (Cleveland) Inc II Apr-01-2015
86 Philips Medical Systems (Cleveland) Inc II Jan-15-2015
87 Philips Medical Systems (Cleveland) Inc II Dec-16-2014
88 Philips Medical Systems (Cleveland) Inc II Dec-01-2014
89 Philips Medical Systems (Cleveland) Inc II Sep-29-2014
90 Philips Medical Systems (Cleveland) Inc II Sep-26-2014
91 Philips Medical Systems (Cleveland) Inc II Sep-18-2014
92 Philips Medical Systems (Cleveland) Inc II Sep-18-2014
93 Philips Medical Systems (Cleveland) Inc II Aug-14-2014
94 Philips Medical Systems (Cleveland) Inc II Jun-22-2014
95 Philips Medical Systems (Cleveland) Inc II Jun-04-2014
96 Philips Medical Systems (Cleveland) Inc II Apr-16-2014
97 Philips Medical Systems (Cleveland) Inc II Jan-29-2014
98 Philips Medical Systems (Cleveland) Inc II Jan-27-2014
99 Philips Medical Systems (Cleveland) Inc II Jan-27-2014
100 Philips Medical Systems (Cleveland) Inc II Jan-21-2014
101 Philips Medical Systems (Cleveland) Inc II Nov-15-2013
102 Philips Medical Systems (Cleveland) Inc II Oct-17-2013
103 Philips Medical Systems (Cleveland) Inc II Oct-17-2013
104 Philips Medical Systems (Cleveland) Inc II Sep-16-2013
105 Philips Medical Systems (Cleveland) Inc II Jul-02-2013
106 Philips Medical Systems (Cleveland) Inc II Jun-25-2013
107 Philips Medical Systems (Cleveland) Inc II May-20-2013
108 Philips Medical Systems (Cleveland) Inc II Apr-12-2013
109 Philips Medical Systems (Cleveland) Inc II Mar-14-2013
110 Philips Medical Systems (Cleveland) Inc II Mar-13-2013
111 Philips Medical Systems (Cleveland) Inc II Mar-05-2013
112 Philips Medical Systems (Cleveland) Inc II Feb-28-2013
113 Philips Medical Systems (Cleveland) Inc II Feb-26-2013
114 Philips Medical Systems (Cleveland) Inc II Feb-26-2013
115 Philips Medical Systems (Cleveland) Inc II Jan-16-2013
116 Philips Medical Systems (Cleveland) Inc II Jan-15-2013
117 Philips Medical Systems (Cleveland) Inc II Sep-25-2012
118 Philips Medical Systems (Cleveland) Inc III Sep-19-2012
119 Philips Medical Systems (Cleveland) Inc II Sep-14-2012
120 Philips Medical Systems (Cleveland) Inc II Aug-22-2012
121 Philips Medical Systems (Cleveland) Inc II Aug-17-2012
122 Philips Medical Systems (Cleveland) Inc II Jul-19-2012
123 Philips Medical Systems (Cleveland) Inc II Jul-12-2012
124 Philips Medical Systems (Cleveland) Inc II Jul-11-2012
125 Philips Medical Systems (Cleveland) Inc II Jul-11-2012
126 Philips Medical Systems (Cleveland) Inc II Jun-08-2012
127 Philips Medical Systems (Cleveland) Inc II May-30-2012
128 Philips Medical Systems (Cleveland) Inc II May-30-2012
129 Philips Medical Systems (Cleveland) Inc II Apr-05-2012
130 Philips Medical Systems (Cleveland) Inc II Apr-02-2012
131 Philips Medical Systems (Cleveland) Inc II Mar-23-2012
132 Philips Medical Systems (Cleveland) Inc II Feb-16-2012
133 Philips Medical Systems (Cleveland) Inc II Feb-03-2012
134 Philips Medical Systems (Cleveland) Inc II Jan-24-2012
135 Philips Medical Systems (Cleveland) Inc II Jan-17-2012
136 Philips Medical Systems (Cleveland) Inc II Jan-11-2012
137 Philips Medical Systems (Cleveland) Inc II Dec-02-2011
138 Philips Medical Systems (Cleveland) Inc II Dec-01-2011
139 Philips Medical Systems (Cleveland) Inc II Sep-27-2011
140 Philips Medical Systems (Cleveland) Inc II Sep-14-2011
141 Philips Medical Systems (Cleveland) Inc II Sep-13-2011
142 Philips Medical Systems (Cleveland) Inc II May-19-2011
143 Philips Medical Systems (Cleveland) Inc II Apr-26-2011
144 Philips Medical Systems (Cleveland) Inc II Mar-24-2011
145 Philips Medical Systems (Cleveland) Inc II Oct-22-2010
146 Philips Medical Systems (Cleveland) Inc II Sep-22-2010
147 Philips Medical Systems (Cleveland) Inc II Nov-17-2009
148 Philips Medical Systems (Cleveland) Inc II Nov-13-2009
149 Philips Medical Systems (Cleveland) Inc II Jul-13-2009
150 Philips Medical Systems (Cleveland) Inc II Jul-06-2009
151 Philips Medical Systems (Cleveland) Inc II Jun-29-2009
152 Philips Medical Systems (Cleveland) Inc II Dec-29-2007
153 Philips Medical Systems (Cleveland) Inc II Nov-21-2007
154 Philips Medical Systems (Cleveland) Inc II Nov-07-2007
155 Philips Medical Systems (Cleveland) Inc II Oct-31-2007
156 Philips Medical Systems (Cleveland) Inc II Sep-13-2007
157 Philips Medical Systems North America Co. Phillips II Jul-09-2011
158 Philips Medical Systems North America Co. Phillips II May-19-2011
159 Philips Medical Systems, Inc. II Dec-16-2014
160 Philips and Neusoft Medical Systems Co., Ltd. II Apr-27-2016
161 Siemens Medical Solutions USA, Inc II Jun-21-2017
162 Siemens Medical Solutions USA, Inc II Dec-12-2016
163 Siemens Medical Solutions USA, Inc II Dec-02-2016
164 Siemens Medical Solutions USA, Inc II Nov-17-2016
165 Siemens Medical Solutions USA, Inc II Nov-17-2016
166 Siemens Medical Solutions USA, Inc II Nov-08-2016
167 Siemens Medical Solutions USA, Inc II Aug-23-2016
168 Siemens Medical Solutions USA, Inc II Apr-22-2016
169 Siemens Medical Solutions USA, Inc II Apr-19-2016
170 Siemens Medical Solutions USA, Inc II Apr-08-2016
171 Siemens Medical Solutions USA, Inc II Mar-31-2016
172 Siemens Medical Solutions USA, Inc II Oct-06-2015
173 Siemens Medical Solutions USA, Inc II Oct-05-2015
174 Siemens Medical Solutions USA, Inc II Jun-27-2015
175 Siemens Medical Solutions USA, Inc II May-22-2015
176 Siemens Medical Solutions USA, Inc II Mar-12-2015
177 Siemens Medical Solutions USA, Inc II Jan-14-2015
178 Siemens Medical Solutions USA, Inc II Jun-04-2014
179 Siemens Medical Solutions USA, Inc II Feb-03-2014
180 Siemens Medical Solutions USA, Inc II Mar-14-2013
181 Siemens Medical Solutions USA, Inc II Jul-30-2009
182 Siemens Medical Solutions USA, Inc II Jun-16-2009
183 Siemens Medical Solutions USA, Inc II Jan-23-2009
184 Siemens Medical Solutions USA, Inc II Jan-05-2009
185 Siemens Medical Solutions USA, Inc II Sep-21-2008
186 Siemens Medical Solutions USA, Inc. II Jan-21-2016
187 Siemens Medical Solutions USA, Inc. II Nov-23-2011
188 Siemens Medical Solutions USA, Inc. II Dec-29-2009
189 Siemens Medical Solutions USA, Inc. II Feb-23-2007
190 SuperDimension, Inc. II Mar-29-2007
191 Toshiba American Med Sys Inc II Sep-29-2008
192 Toshiba American Medical Systems Inc II Nov-18-2016
193 Toshiba American Medical Systems Inc II Oct-06-2016
194 Toshiba American Medical Systems Inc II Apr-22-2016
195 Toshiba American Medical Systems Inc II Oct-09-2015
196 Toshiba American Medical Systems Inc II Nov-26-2014
197 Toshiba American Medical Systems Inc II Mar-06-2014
198 Toshiba American Medical Systems Inc II Mar-03-2014
199 Toshiba American Medical Systems Inc II Apr-08-2013
200 Toshiba American Medical Systems Inc II Apr-08-2013
201 Toshiba American Medical Systems Inc II Sep-27-2012
202 Toshiba American Medical Systems Inc II Aug-28-2012
203 Toshiba American Medical Systems Inc II Aug-24-2012
204 Toshiba American Medical Systems Inc II Feb-15-2012
205 Toshiba American Medical Systems Inc II Sep-16-2011
206 Toshiba American Medical Systems Inc II Sep-13-2011
207 Toshiba American Medical Systems Inc II Jul-29-2011
208 Toshiba American Medical Systems Inc II May-19-2011
209 Toshiba American Medical Systems Inc II Mar-16-2011
210 Toshiba American Medical Systems Inc II Feb-15-2011
211 Toshiba American Medical Systems Inc II Sep-01-2010
212 Toshiba American Medical Systems Inc II Mar-19-2010
213 Toshiba American Medical Systems Inc II Mar-02-2010
214 Xoran Technologies, Inc. II Jun-26-2015
215 Xoran Technologies, Inc. II Jun-26-2015
216 Xoran Technologies, Inc. II Jun-26-2015
217 Xoran Technologies, Inc. II Jun-26-2015
218 Xoran Technologies, Inc. II Jun-26-2015
219 Xoran Technologies, Inc. II Dec-23-2009
220 Xoran Technologies, Inc. III Feb-07-2008
221 Xoran Technologies, Inc. II Nov-27-2007
222 Xoran Technologies, LLC II Mar-02-2015

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