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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, tomography, computed, emission
Regulation Description Emission computed tomography system.
Product CodeKPS
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 35
CMSI
  SUBSTANTIALLY EQUIVALENT 1
CTI PET SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 18
DANISH DIAGNOSTIC
  SUBSTANTIALLY EQUIVALENT 5
EMORY UNIVERSITY
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 54
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
Naviscan PET Systems
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 19
SIEMENS
  SUBSTANTIALLY EQUIVALENT 29
SMV
  SUBSTANTIALLY EQUIVALENT 7
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Device operates differently than expected 5
No Known Device Problem 5
Mechanical issue 4
Use of Device Issue 3
Positioning Issue 3
Unintended movement 3
No Information 2
No code available 2
Leak 2
Improper or incorrect procedure or method 2
Smoking 2
Break 2
Unintended collision 2
Overheating of device or device component 1
User used incorrect product for intended use 1
Inadequate service 1
Detachment of device component 1
Component falling 1
Degraded 1
Device inoperable 1
Misassembled 1
Device emits odor 1
Defective component 1
Tipover 1
Deployment issue 1
Device handling issue 1
Noise, Audible 1
Misassembled by Users 1
Protective measure issue 1
Failure to shut off 1
Human-Device Interface Issue 1
Material integrity issue 1
Total Device Problems 56

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 5 7 13 1 13 14 11 17 16 10 7
Class III 1 1 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Sep-21-2015
2 GE Healthcare II Mar-13-2015
3 GE Healthcare II Sep-05-2008
4 GE Healthcare, LLC II Jun-12-2017
5 GE Healthcare, LLC II Dec-16-2014
6 GE Healthcare, LLC II Mar-13-2014
7 GE Healthcare, LLC II Feb-14-2014
8 GE Healthcare, LLC II Nov-20-2013
9 GE Healthcare, LLC II Oct-17-2013
10 GE Healthcare, LLC II Aug-20-2013
11 GE Healthcare, LLC I Jul-24-2013
12 GE Healthcare, LLC II Apr-24-2013
13 GE Healthcare, LLC II Apr-10-2013
14 GE Healthcare, LLC II Oct-23-2012
15 GE Healthcare, LLC II Feb-27-2012
16 GE Medical Systems, LLC II Mar-04-2016
17 GE Medical Systems, LLC II Sep-17-2009
18 GE Medical Systems, LLC II Apr-21-2009
19 GE Medical Systems, LLC II Apr-10-2009
20 GE Medical Systems, LLC II Apr-10-2009
21 Naviscan PET Systems II Sep-11-2008
22 Naviscan PET Systems III Oct-11-2007
23 Philips Medical Systems II Jan-11-2012
24 Philips Medical Systems II Nov-19-2011
25 Philips Medical Systems II Aug-04-2011
26 Philips Medical Systems II Jul-22-2011
27 Philips Medical Systems II May-09-2011
28 Philips Medical Systems II Mar-04-2011
29 Philips Medical Systems II Nov-17-2010
30 Philips Medical Systems (Cleveland) Inc II Apr-06-2017
31 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
32 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
33 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
34 Philips Medical Systems (Cleveland) Inc II Sep-03-2016
35 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
36 Philips Medical Systems (Cleveland) Inc II Feb-26-2016
37 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
38 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
39 Philips Medical Systems (Cleveland) Inc II May-28-2015
40 Philips Medical Systems (Cleveland) Inc II May-12-2015
41 Philips Medical Systems (Cleveland) Inc II Jan-26-2015
42 Philips Medical Systems (Cleveland) Inc II Dec-01-2014
43 Philips Medical Systems (Cleveland) Inc II Jul-10-2014
44 Philips Medical Systems (Cleveland) Inc II Jul-02-2014
45 Philips Medical Systems (Cleveland) Inc II Jun-02-2014
46 Philips Medical Systems (Cleveland) Inc II Apr-26-2014
47 Philips Medical Systems (Cleveland) Inc II Apr-16-2014
48 Philips Medical Systems (Cleveland) Inc II Feb-24-2014
49 Philips Medical Systems (Cleveland) Inc II Feb-12-2014
50 Philips Medical Systems (Cleveland) Inc II Feb-04-2014
51 Philips Medical Systems (Cleveland) Inc II Oct-28-2013
52 Philips Medical Systems (Cleveland) Inc II Oct-25-2013
53 Philips Medical Systems (Cleveland) Inc II Jun-05-2013
54 Philips Medical Systems (Cleveland) Inc II Apr-01-2013
55 Philips Medical Systems (Cleveland) Inc II Feb-28-2013
56 Philips Medical Systems (Cleveland) Inc II Feb-26-2013
57 Philips Medical Systems (Cleveland) Inc II Dec-21-2012
58 Philips Medical Systems (Cleveland) Inc II Aug-22-2012
59 Philips Medical Systems (Cleveland) Inc II Apr-05-2012
60 Philips Medical Systems (Cleveland) Inc II Mar-30-2012
61 Philips Medical Systems (Cleveland) Inc II Mar-16-2012
62 Philips Medical Systems (Cleveland) Inc II Feb-17-2012
63 Philips Medical Systems (Cleveland) Inc II Feb-10-2012
64 Philips Medical Systems (Cleveland) Inc II Feb-02-2012
65 Philips Medical Systems (Cleveland) Inc II Jan-18-2012
66 Philips Medical Systems (Cleveland) Inc II Dec-01-2011
67 Philips Medical Systems (Cleveland) Inc II Sep-13-2011
68 Philips Medical Systems (Cleveland) Inc II Aug-01-2011
69 Philips Medical Systems (Cleveland) Inc II Aug-01-2011
70 Philips Medical Systems (Cleveland) Inc II Mar-24-2011
71 Philips Medical Systems (Cleveland) Inc II Mar-16-2011
72 Philips Medical Systems (Cleveland) Inc II Jul-06-2009
73 Philips Medical Systems (Cleveland) Inc II Jul-06-2009
74 Philips Medical Systems (Cleveland) Inc II Jan-16-2009
75 Philips Medical Systems (Cleveland) Inc II Oct-28-2008
76 Philips Medical Systems (Cleveland) Inc III Sep-19-2008
77 Philips Medical Systems (Cleveland) Inc II Jan-31-2008
78 Philips Medical Systems (Cleveland) Inc II Sep-26-2007
79 Philips Medical Systems, Inc. II Dec-12-2014
80 Phillips Nuclear Medicine II Sep-16-2009
81 Phillips Nuclear Medicine II Feb-08-2008
82 Siemens Medical Solutions USA Inc II Jan-04-2008
83 Siemens Medical Solutions USA Inc II Nov-29-2007
84 Siemens Medical Solutions USA Inc. II Feb-28-2017
85 Siemens Medical Solutions USA Inc. II Jan-10-2017
86 Siemens Medical Solutions USA Inc. II Jun-21-2016
87 Siemens Medical Solutions USA Inc. II Jun-15-2016
88 Siemens Medical Solutions USA Inc. II Aug-05-2015
89 Siemens Medical Solutions USA Inc. II Dec-16-2014
90 Siemens Medical Solutions USA Inc. II Nov-10-2009
91 Siemens Medical Solutions USA, Inc. II Oct-25-2017
92 Siemens Medical Solutions USA, Inc. II Oct-08-2016
93 Siemens Medical Solutions USA, Inc. II Mar-25-2016
94 Siemens Medical Solutions USA, Inc. II Nov-04-2015
95 Siemens Medical Solutions USA, Inc. II Aug-20-2015
96 Siemens Medical Solutions USA, Inc. II Mar-19-2015
97 Siemens Medical Solutions USA, Inc. II Feb-10-2015
98 Siemens Medical Solutions USA, Inc. II Jan-13-2015
99 Siemens Medical Solutions USA, Inc. II Jan-06-2015
100 Siemens Medical Solutions USA, Inc. II Jan-06-2015
101 Siemens Medical Solutions USA, Inc. II Oct-22-2014
102 Siemens Medical Solutions USA, Inc. II Sep-29-2014
103 Siemens Medical Solutions USA, Inc. II Jul-11-2014
104 Siemens Medical Solutions USA, Inc. II May-30-2012
105 Siemens Medical Solutions USA, Inc. II Nov-23-2011
106 Siemens Medical Solutions USA, Inc. II Aug-10-2011
107 Siemens Medical Solutions USA, Inc. II Dec-29-2009
108 Siemens Medical Solutions USA, Inc. II Aug-04-2009
109 Siemens Medical Solutions USA, Inc. II Jul-07-2009
110 Siemens Medical Solutions USA, Inc. II Jun-24-2009
111 Siemens Medical Solutions USA, Inc. II Oct-27-2008
112 Siemens Medical Solutions USA, Inc. II Dec-19-2007
113 Siemens Medical Solutions USA, Inc. II Jun-06-2007
114 Siemens Medical Solutions USA, Inc. II Feb-23-2007
115 Spectrum Dynamics II Mar-21-2012
116 Toshiba American Medical Systems Inc II Oct-06-2016
117 Toshiba American Medical Systems Inc II May-04-2016
118 Toshiba American Medical Systems Inc II Oct-07-2015

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