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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 26
SMV
  SUBSTANTIALLY EQUIVALENT 7
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Device operates differently than expected 5
Unintended movement 3
Mechanical issue 3
Smoking 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Break 2
Unintended collision 2
Leak 2
No Information 2
No code available 2
Device handling issue 1
Noise, Audible 1
Failure to shut off 1
Human-Device Interface Issue 1
Material integrity issue 1
No Known Device Problem 1
Protective measure issue 1
Misassembled by Users 1
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
Defective component 1
Deployment issue 1
Device inoperable 1
Misassembled 1
Device emits odor 1
Total Device Problems 46

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 0
Class II 5 7 13 1 13 14 11 17 16 8
Class III 1 1 0 0 0 0 0 0 0 0

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

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