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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 47

Device Problems
Computer software issue 73
Device operates differently than expected 14
No Known Device Problem 8
Use of Device Issue 5
Improper or incorrect procedure or method 5
Detachment of device component 5
Unintended collision 4
Positioning Issue 4
Instruction for use issue 3
Electrical issue 3
Incompatibility problem 2
Application interface becomes non-functional or program exits abnormally 2
Unexpected therapeutic results 2
Human-Device Interface Issue 2
Incorrect display 2
Incorrect or inadequate result 2
Detachment of device or device component 2
Unintended movement 2
Application program issue 2
Protective measure issue 2
Misassembled by Users 2
Use of Incorrect Control Settings 1
Computer operating system issue 1
Mechanical jam 1
Operating system version or upgrade problem 1
Arcing 1
Electrical overstress 1
No Information 1
Mechanical issue 1
Nonstandard device or device component 1
Calibration error 1
Component falling 1
Loose or intermittent connection 1
Malposition of device 1
Manufacturing or shipping issue associated with device 1
Moisture or humidity problem 1
Programming issue 1
Fracture 1
Migration of device or device component 1
Failure to sense 1
Inappropriate shock 1
Device stops intermittently 1
Low readings 1
Loss of Data 1
Material integrity issue 1
Data Issue 1
Misassembled 1
Device displays error message 1
No code available 1
No display or display failure 1
Inadequate instructions for healthcare professional 1
Incorrect measurement 1
Total Device Problems 177

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

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