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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 11
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 32
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHAERER MAYFIELD
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 92
SUPERDIMENSION, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 64
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No Known Device Problem 207
Device operates differently than expected 123
Unknown (for use when the device problem is not known) 94
Mechanical issue 92
Unintended system motion 42
Detachment of device or device component 31
Artifact 29
Detachment of device component 27
Unintended movement 24
Use of Device Issue 21
Positioning Issue 13
No Information 12
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 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
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
Smoking 3
Self-activation or keying 3
Power source issue 3
Programming issue 2
Mechanics altered 2
Human-Device Interface Issue 2
Device handling issue 2
Noise, Audible 2
Temperature issue 2
Not Applicable 2
Device inoperable 2
Malposition of device 2
Connection issue 2
Deployment issue 2
Difficult to advance 2
Loss of power 2
Output above specifications 2
Overheating of device or device component 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
Fail-safe design failure 1
Erratic display 1
Incorrect display 1
Image reversal 1
Device abrasion from instrument or another object 1
Difficult to position 1
Power Conditioning Issue 1
Failure to power-up 1
Premature deployment 1
Dislodged or dislocated 1
Environmental control or utility issue 1
Gas leak 1
Computer operating system issue 1
Patient-device incompatibility 1
Application program issue 1
Sensor problems 1
Retraction problem 1
Tears, rips, holes in device, device material 1
Inadequate training 1
Metal shedding debris 1
Component missing 1
Device Issue 1
Malfunction 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 968

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 34
Class III 0 1 0 0 0 1 0 0 0 1

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

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