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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accelerator, linear, medical
Regulation Description Medical charged-particle radiation therapy system.
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY, INC.
  SUBSTANTIALLY EQUIVALENT 4
ADAC
  SUBSTANTIALLY EQUIVALENT 6
BIONX
  SUBSTANTIALLY EQUIVALENT 10
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 13
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CIVCO
  SUBSTANTIALLY EQUIVALENT 2
COMPUTERIZED MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 19
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
HUESTIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPAC
  SUBSTANTIALLY EQUIVALENT 8
LEIBINGER
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC
  SUBSTANTIALLY EQUIVALENT 3
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 5
NOMOS
  SUBSTANTIALLY EQUIVALENT 12
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 12
RADIATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 6
RADIONICS, INC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 17
STANDARD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
TomoTherapy
  SUBSTANTIALLY EQUIVALENT 2
VARIAN
  SUBSTANTIALLY EQUIVALENT 49

Device Problems
Computer software issue 114
Device operates differently than expected 15
No Known Device Problem 11
Detachment of device component 5
Use of Device Issue 5
Improper or incorrect procedure or method 5
Unintended collision 4
Positioning Issue 4
Detachment of device or device component 3
Electrical issue 3
Instruction for use issue 3
Loose or intermittent connection 2
Component falling 2
Application interface becomes non-functional or program exits abnormally 2
Misassembled 2
Incorrect or inadequate result 2
Incorrect display 2
Unexpected therapeutic results 2
Component missing 2
Loss of Data 2
Application program issue 2
Fail-safe mechanism issue 2
Human-Device Interface Issue 2
Incompatibility problem 2
Operating system version or upgrade problem 2
Protective measure issue 2
Unintended movement 2
Misassembled by Users 2
No Information 1
No code available 1
Data Issue 1
Device handling issue 1
Device-device incompatibility 1
Electrical overstress 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanical jam 1
Moisture or humidity problem 1
Computer operating system issue 1
Power source issue 1
Programming issue 1
Low readings 1
Arcing 1
Device displays error message 1
Malposition of device 1
Application network issue 1
Prompts will not clear 1
Failure to sense 1
Inappropriate shock 1
Device stops intermittently 1
Nonstandard device or device component 1
Premature deployment 1
User used incorrect product for intended use 1
No display or display failure 1
Use of Incorrect Control Settings 1
Burn of device or device component 1
Calibration error 1
Device Cleaning Issue 1
Incorrect measurement 1
Mechanical issue 1
Migration of device or device component 1
Inadequate instructions for healthcare professional 1
Fail-safe design failure 1
Fracture 1
Total Device Problems 242

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 13 25 15 12 60 35 17 35 25 21 6
Class III 1 2 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Inc II Jan-18-2011
2 Accuray Inc II Dec-16-2010
3 Accuray Inc II Sep-14-2009
4 Accuray Inc II Jan-17-2009
5 Accuray Inc II Sep-17-2008
6 Accuray Inc II Sep-16-2008
7 Accuray Incorporated II Dec-21-2016
8 Accuray Incorporated II Dec-12-2016
9 Accuray Incorporated II Feb-09-2016
10 Accuray Incorporated II Nov-14-2014
11 Accuray Incorporated II Jan-27-2014
12 Accuray Incorporated II Apr-16-2013
13 Accuray Incorporated II Feb-23-2012
14 Accuray Incorporated II Jan-11-2012
15 Accuray Incorporated II Oct-11-2011
16 Brainlab AG II Jun-08-2016
17 Brainlab AG II Aug-21-2015
18 Brainlab AG II Mar-25-2015
19 Brainlab AG II Aug-04-2014
20 Brainlab AG II Jun-03-2014
21 Brainlab AG II Apr-25-2014
22 Brainlab AG II Aug-26-2013
23 Brainlab AG II Jul-02-2009
24 Civco Medical Instruments Inc II Jan-21-2014
25 Civco Medical Instruments Inc II Sep-18-2008
26 Civco Medical Instruments Inc III May-21-2008
27 Elekta, Inc. II Dec-09-2016
28 Elekta, Inc. II Sep-02-2016
29 Elekta, Inc. II Aug-30-2016
30 Elekta, Inc. II Jul-27-2016
31 Elekta, Inc. II Jun-27-2016
32 Elekta, Inc. II May-23-2016
33 Elekta, Inc. II Dec-29-2015
34 Elekta, Inc. II Dec-17-2015
35 Elekta, Inc. II Jul-14-2015
36 Elekta, Inc. II Jun-26-2015
37 Elekta, Inc. II Feb-10-2015
38 Elekta, Inc. II Nov-15-2014
39 Elekta, Inc. II Jun-25-2014
40 Elekta, Inc. II Jun-17-2014
41 Elekta, Inc. II Jun-16-2014
42 Elekta, Inc. II Jun-16-2014
43 Elekta, Inc. II Apr-02-2014
44 Elekta, Inc. II Mar-14-2014
45 Elekta, Inc. II Mar-07-2014
46 Elekta, Inc. II Mar-06-2014
47 Elekta, Inc. II Mar-06-2014
48 Elekta, Inc. II Mar-06-2014
49 Elekta, Inc. II Feb-20-2014
50 Elekta, Inc. II Feb-20-2014
51 Elekta, Inc. II May-25-2013
52 Elekta, Inc. II Mar-10-2013
53 Elekta, Inc. II Oct-30-2012
54 Elekta, Inc. II Sep-19-2012
55 Elekta, Inc. II Sep-10-2012
56 Elekta, Inc. II May-23-2012
57 Elekta, Inc. II Feb-21-2012
58 Elekta, Inc. II Dec-01-2011
59 Elekta, Inc. II Dec-01-2011
60 Elekta, Inc. II Nov-29-2011
61 Elekta, Inc. II Mar-22-2011
62 Elekta, Inc. II Mar-04-2011
63 Elekta, Inc. II Feb-15-2011
64 Elekta, Inc. II Dec-03-2010
65 Elekta, Inc. II Apr-27-2010
66 Elekta, Inc. II Apr-26-2010
67 Elekta, Inc. II Apr-22-2010
68 Elekta, Inc. II Apr-16-2010
69 Elekta, Inc. II Mar-18-2010
70 Elekta, Inc. III Feb-07-2007
71 Iba Dosimetry II Jun-02-2017
72 Iba Dosimetry Gmbh II Jan-21-2016
73 Iba Dosimetry Gmbh II Feb-26-2015
74 Iba Dosimetry Gmbh II Nov-04-2014
75 Iba Dosimetry Gmbh II Dec-06-2013
76 Impac Medical Systems Inc II Jul-06-2012
77 Impac Medical Systems Inc II Oct-17-2011
78 Impac Medical Systems Inc II Jun-24-2011
79 Impac Medical Systems Inc II Feb-04-2011
80 Impac Medical Systems Inc II Oct-18-2010
81 Impac Medical Systems Inc II Aug-21-2009
82 Impac Medical Systems Inc II Aug-16-2008
83 Integra LifeSciences Corp II Mar-08-2012
84 Ion Beam Applications S.A. II Oct-29-2014
85 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II Mar-31-2016
86 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II Mar-24-2016
87 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II May-01-2015
88 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II Dec-17-2014
89 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II Sep-16-2014
90 MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK II Aug-08-2013
91 Med Tec Inc III Nov-06-2009
92 Med Tec Inc dba CIVCO Medical Solutions III May-21-2008
93 Mobius Medical Systems, LP II May-16-2017
94 Northwest Medical Physics Equipment Inc II Aug-09-2007
95 Northwest Medical Physics Equipment Inc II Aug-08-2007
96 Northwest Medical Physics Equipment Inc II Aug-08-2007
97 Northwest Medical Physics Equipment Inc II Aug-08-2007
98 Northwest Medical Physics Equipment Inc II Aug-08-2007
99 Northwest Medical Physics Equipment Inc II Aug-08-2007
100 Northwest Medical Physics Equipment Inc II Aug-08-2007
101 PTW-Freiburg II Aug-21-2015
102 Philips Medical Systems II Feb-02-2016
103 Philips Medical Systems (Cleveland), Inc. II Nov-05-2012
104 Philips Medical Systems (Cleveland), Inc. II Jan-11-2012
105 Siemens Medical Solutions USA, Inc II Dec-03-2013
106 Siemens Medical Solutions USA, Inc II Aug-26-2013
107 Siemens Medical Solutions USA, Inc II Jul-03-2013
108 Siemens Medical Solutions USA, Inc II Jun-21-2013
109 Siemens Medical Solutions USA, Inc II Apr-26-2013
110 Siemens Medical Solutions USA, Inc II Apr-10-2013
111 Siemens Medical Solutions USA, Inc II Apr-02-2013
112 Siemens Medical Solutions USA, Inc II Mar-05-2013
113 Siemens Medical Solutions USA, Inc II Jul-24-2012
114 Siemens Medical Solutions USA, Inc II May-08-2012
115 Siemens Medical Solutions USA, Inc II May-07-2012
116 Siemens Medical Solutions USA, Inc II May-03-2012
117 Siemens Medical Solutions USA, Inc II Mar-21-2012
118 Siemens Medical Solutions USA, Inc II Feb-23-2012
119 Siemens Medical Solutions USA, Inc II Jan-17-2012
120 Siemens Medical Solutions USA, Inc II Jan-11-2012
121 Siemens Medical Solutions USA, Inc II Jan-11-2012
122 Siemens Medical Solutions USA, Inc II Aug-11-2011
123 Siemens Medical Solutions USA, Inc II Aug-10-2011
124 Siemens Medical Solutions USA, Inc II Jul-11-2011
125 Siemens Medical Solutions USA, Inc II Jun-02-2011
126 Siemens Medical Solutions USA, Inc II May-23-2011
127 Siemens Medical Solutions USA, Inc II May-19-2011
128 Siemens Medical Solutions USA, Inc II May-12-2011
129 Siemens Medical Solutions USA, Inc II Apr-15-2011
130 Siemens Medical Solutions USA, Inc II Apr-13-2011
131 Siemens Medical Solutions USA, Inc II Mar-07-2011
132 Siemens Medical Solutions USA, Inc II Mar-04-2011
133 Siemens Medical Solutions USA, Inc II Feb-08-2011
134 Siemens Medical Solutions USA, Inc II Nov-24-2010
135 Siemens Medical Solutions USA, Inc II Nov-05-2009
136 Siemens Medical Solutions USA, Inc II Sep-24-2009
137 Siemens Medical Solutions USA, Inc II Jan-30-2009
138 Siemens Medical Solutions USA, Inc II Jan-29-2009
139 Siemens Medical Solutions USA, Inc II Jan-14-2009
140 Siemens Medical Solutions USA, Inc II Oct-20-2008
141 Siemens Medical Solutions USA, Inc II Oct-16-2008
142 Siemens Medical Solutions USA, Inc II Sep-29-2008
143 Siemens Medical Solutions USA, Inc II Sep-17-2008
144 Siemens Medical Solutions USA, Inc II Sep-04-2008
145 Siemens Medical Solutions USA, Inc II Aug-20-2008
146 Siemens Medical Solutions USA, Inc II Apr-30-2008
147 Siemens Medical Solutions USA, Inc II Apr-02-2008
148 Siemens Medical Solutions USA, Inc II Feb-19-2008
149 Siemens Medical Solutions USA, Inc II Feb-14-2008
150 Siemens Medical Solutions USA, Inc II Dec-01-2007
151 Siemens Medical Solutions USA, Inc II Nov-09-2007
152 Siemens Medical Solutions USA, Inc II Mar-20-2017
153 Siemens Medical Solutions USA, Inc II Mar-09-2017
154 Siemens Medical Solutions USA, Inc II Feb-16-2017
155 Siemens Medical Solutions USA, Inc II Sep-23-2016
156 Siemens Medical Solutions USA, Inc II Oct-27-2015
157 Siemens Medical Solutions USA, Inc II Oct-06-2015
158 Siemens Medical Solutions USA, Inc II Sep-24-2015
159 Siemens Medical Solutions USA, Inc II Mar-18-2015
160 Siemens Medical Solutions USA, Inc II Mar-16-2015
161 Siemens Medical Solutions USA, Inc II Feb-05-2015
162 Siemens Medical Solutions USA, Inc II Jan-26-2015
163 Siemens Medical Solutions USA, Inc II Jan-15-2015
164 Siemens Medical Solutions USA, Inc II Aug-10-2014
165 Siemens Medical Solutions USA, Inc II Aug-10-2014
166 Siemens Medical Solutions USA, Inc II Jun-20-2014
167 Siemens Medical Solutions USA, Inc II May-23-2014
168 Siemens Medical Solutions USA, Inc II May-21-2014
169 Siemens Medical Solutions USA, Inc - Radiation Oncology II Jun-23-2011
170 Siemens Medical Solutions USA, Inc., Concord, CA II Feb-24-2011
171 Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510 II Jan-18-2011
172 Sun Nuclear Corporation II Jan-13-2015
173 TomoTherapy Incorporated II Dec-12-2014
174 TomoTherapy Incorporated II Aug-15-2014
175 TomoTherapy Incorporated II Aug-15-2014
176 TomoTherapy Incorporated II Jan-22-2009
177 TomoTherapy Incorporated II Jan-05-2009
178 TomoTherapy Incorporated II Aug-24-2008
179 Varian Medical Systems Inc II Feb-15-2008
180 Varian Medical Systems Inc II Feb-14-2008
181 Varian Medical Systems Inc II Jan-29-2008
182 Varian Medical Systems Inc II Aug-29-2007
183 Varian Medical Systems Inc II Jul-12-2007
184 Varian Medical Systems Inc II Jun-28-2007
185 Varian Medical Systems Inc. II Dec-28-2010
186 Varian Medical Systems Oncology Systems II Feb-15-2011
187 Varian Medical Systems Oncology Systems II Feb-01-2011
188 Varian Medical Systems Oncology Systems II Jan-31-2011
189 Varian Medical Systems Oncology Systems II Jan-18-2011
190 Varian Medical Systems Oncology Systems II Jan-10-2011
191 Varian Medical Systems Oncology Systems II Jan-10-2011
192 Varian Medical Systems Oncology Systems II Dec-29-2010
193 Varian Medical Systems Oncology Systems II Oct-20-2010
194 Varian Medical Systems Oncology Systems II Nov-09-2009
195 Varian Medical Systems Oncology Systems II Aug-27-2009
196 Varian Medical Systems Oncology Systems II Aug-27-2009
197 Varian Medical Systems Oncology Systems II Feb-20-2009
198 Varian Medical Systems Oncology Systems II Oct-22-2008
199 Varian Medical Systems Oncology Systems II Oct-20-2008
200 Varian Medical Systems Oncology Systems II Sep-17-2008
201 Varian Medical Systems Oncology Systems II Sep-16-2008
202 Varian Medical Systems Oncology Systems II Sep-04-2008
203 Varian Medical Systems Oncology Systems II Aug-15-2008
204 Varian Medical Systems Oncology Systems II Aug-02-2008
205 Varian Medical Systems Oncology Systems II Jun-06-2007
206 Varian Medical Systems, Inc. II Jan-10-2017
207 Varian Medical Systems, Inc. II Oct-13-2016
208 Varian Medical Systems, Inc. II Jul-11-2016
209 Varian Medical Systems, Inc. II Dec-16-2014
210 Varian Medical Systems, Inc. II Sep-13-2014
211 Varian Medical Systems, Inc. II Apr-24-2014
212 Varian Medical Systems, Inc. II Dec-03-2013
213 Varian Medical Systems, Inc. II Sep-14-2011
214 Varian Medical Systems, Inc. Oncology Systems II Jun-26-2015
215 Varian Medical Systems, Inc. Oncology Systems II May-15-2013
216 Varian Medical Systems, Inc. Oncology Systems II Apr-23-2013
217 Varian Medical Systems, Inc. Oncology Systems II Dec-17-2012
218 Varian Medical Systems, Inc. Oncology Systems II Nov-01-2012
219 Varian Medical Systems, Inc. Oncology Systems II Sep-14-2012
220 Varian Medical Systems, Inc. Oncology Systems II Aug-08-2012
221 Varian Medical Systems, Inc. Oncology Systems II May-16-2012
222 Varian Medical Systems, Inc. Oncology Systems II May-08-2012
223 Varian Medical Systems, Inc. Oncology Systems II Mar-16-2012
224 Varian Medical Systems, Inc. Oncology Systems II Mar-06-2012
225 Varian Medical Systems, Inc. Oncology Systems II Feb-23-2012
226 Varian Medical Systems, Inc. Oncology Systems II Feb-03-2012
227 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
228 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
229 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
230 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
231 Varian Medical Systems, Inc. Oncology Systems II Jan-11-2012
232 Varian Medical Systems, Inc. Oncology Systems II Dec-02-2011
233 Varian Medical Systems, Inc. Oncology Systems II Dec-01-2011
234 Varian Medical Systems, Inc. Oncology Systems II Nov-09-2011
235 Varian Medical Systems, Inc. Oncology Systems II Sep-14-2011
236 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
237 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
238 Varian Medical Systems, Inc. Oncology Systems II Aug-31-2011
239 Varian Medical Systems, Inc. Oncology Systems II Aug-30-2011
240 Varian Medical Systems, Inc. Oncology Systems II Aug-22-2011
241 Varian Medical Systems, Inc. Oncology Systems II Aug-10-2011
242 Varian Medical Systems, Inc. Oncology Systems II Jul-28-2011
243 Varian Medical Systems, Inc. Oncology Systems II Jul-11-2011
244 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
245 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
246 Varian Medical Systems, Inc. Oncology Systems II Jul-08-2011
247 Varian Medical Systems, Inc. Oncology Systems II May-20-2011
248 Varian Medical Systems, Inc. Oncology Systems II May-16-2011
249 Varian Medical Systems, Inc. Oncology Systems II May-13-2011
250 Varian Medical Systems, Inc. Oncology Systems II May-10-2011
251 Varian Medical Systems, Inc. Oncology Systems II May-10-2011
252 Varian Medical Systems, Inc. Oncology Systems II May-02-2011
253 Varian Medical Systems, Inc. Oncology Systems II Apr-29-2011
254 Varian Medical Systems, Inc. Oncology Systems II Apr-25-2011
255 Varian Medical Systems, Inc. Oncology Systems II Apr-12-2011
256 Varian Medical Systems, Inc. Oncology Systems II Apr-07-2011
257 Varian Medical Systems, Inc. Oncology Systems II Feb-08-2011
258 Varian Medical Systems, Inc. Oncology Systems II Jan-21-2011
259 Viewray Incorporated II Mar-31-2016
260 Viewray Incorporated II Feb-12-2016
261 Viewray Incorporated II Oct-09-2015
262 Viewray Incorporated II Jul-16-2015
263 Viewray Incorporated II Jul-02-2015
264 Viewray Incorporated II May-05-2015
265 Vision RT Ltd II Aug-25-2016
266 Vision Rt Inc II Jan-07-2015
267 Vision Rt Inc II Dec-16-2014
268 Wfr/aquaplast Corp II Mar-25-2016

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