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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
ANALOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ARINETA LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 3
CURVEBEAM
  SUBSTANTIALLY EQUIVALENT 2
EDDA TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 6
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 7
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MOBIUS IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 5
QR S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 40
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 37
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 12
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Adverse Event Without Identified Device or Use Problem 374
Device Operates Differently Than Expected 118
Mechanical Problem 100
Use of Device Problem 48
Unintended System Motion 46
Device Operational Issue 39
Detachment of Device or device Component 35
Application Program Problem 34
Device Displays Incorrect Message 30
Material Fragmentation 28
Detachment Of Device Component 26
Improper or Incorrect Procedure or Method 24
Patient Data Problem 23
Signal Artifact 23
Unintended Movement 21
Application Network Problem 20
Computer Software Problem 17
Insufficient Information 16
Image Display Error / Artifact 14
Positioning Problem 12
Human-Device Interface Problem 11
Output Problem 10
Connection Problem 10
Incorrect, Inadequate or Imprecise Result or Readings 10
Mechanical Jam 9
Programming Issue 9
Break 8
Data Problem 8
Poor Quality Image 8
Device Handling Problem 7
Patient Device Interaction Problem 6
Material Deformation 6
Electrical /Electronic Property Problem 6
Calibration Problem 6
Display or Visual Feedback Problem 6
Inadequate User Interface 5
Leak / Splash 5
Communication or Transmission Problem 5
Migration or Expulsion of Device 4
Device Stops Intermittently 4
Defective Device 4
Application Program Freezes, Becomes Nonfunctional 4
Improper Device Output 4
Overheating of Device 4
Unintended Collision 4
Radiofrequency Interference (RFI) 3
Loose or Intermittent Connection 3
No Display / Image 3
Power Problem 3
Sticking 3
Installation-Related Problem 3
Material Integrity Problem 3
Program or Algorithm Execution Problem 3
Device Fell 2
Component or Accessory Incompatibility 2
Incorrect Measurement 2
Output above Specifications 2
Failure to Power Up 2
Device Issue 2
Unintended Electrical Shock 2
Computer Operating System Problem 2
Difficult to Advance 2
Device Alarm System 2
Loss of Power 2
Battery Problem 2
Radiation Overexposure 2
Human Factors Issue 2
Smoking 2
Device Inoperable 2
Incorrect Or Inadequate Test Results 2
Malposition of device 2
Fuse 2
Mechanics Altered 2
Activation, Positioning or Separation Problem 2
Device Damaged Prior to Use 2
Thermal Decomposition of Device 2
Disconnection 2
Difficult to Insert 1
Unstable 1
Obstruction of Flow 1
Unintended Application Program Shut Down 1
Device Misassembled During Manufacturing / Shipping 1
Protective Measures Problem 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Positioning Failure 1
Device Maintenance Issue 1
Device Slipped 1
Chemical Spillage 1
Electrical Shorting 1
Automatic Injection System 1
Device Component Or Accessory 1
Table Top 1
Date/Time-Related Software Problem 1
Sharp Edges 1
Component Missing 1
Difficult To Position 1
Application Program Problem: Dose Calculation Error 1
Fire 1
Circuit Failure 1
Erratic or Intermittent Display 1
Total Device Problems 1306

Recalls
Manufacturer Recall Class Date Posted
1 Bayer Medical Care, Inc. II Aug-31-2018
2 Brainlab AG II Feb-03-2018
3 Canon Medical System, USA, INC. II Apr-10-2020
4 Carestream Health, Inc. II Apr-23-2019
5 GE Healthcare II Sep-21-2015
6 GE Healthcare II May-15-2015
7 GE Healthcare II Jan-26-2015
8 GE Healthcare II Jan-15-2015
9 GE Healthcare Japan Corporation II Aug-17-2018
10 GE Healthcare, LLC II Jul-12-2019
11 GE Healthcare, LLC II May-03-2019
12 GE Healthcare, LLC II Feb-06-2019
13 GE Healthcare, LLC II Jul-31-2018
14 GE Healthcare, LLC II Jun-12-2017
15 GE Healthcare, LLC II Jun-06-2016
16 GE Medical Systems, LLC II Apr-29-2016
17 GE Medical Systems, LLC II Mar-04-2016
18 GE Medical Systems, LLC II Dec-10-2015
19 Hitachi Medical Systems America Inc II Nov-01-2019
20 Hitachi Medical Systems America Inc II Aug-17-2018
21 Hitachi Medical Systems America Inc II Aug-11-2016
22 Imactis II Jan-22-2020
23 Mobius Imaging, LLC II Sep-14-2018
24 Mobius Imaging, LLC II Feb-24-2018
25 Mobius Imaging, LLC II Jan-27-2015
26 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
27 Neusoft Medical System Co II Jun-16-2015
28 Neusoft Medical Systems Co., Ltd. II May-21-2019
29 Neusoft Medical Systems Co., Ltd. II Aug-28-2017
30 Neusoft Medical Systems Co., Ltd. II Dec-23-2016
31 Neusoft Medical Systems Co., Ltd. II May-11-2016
32 Northridge Tri-Modality Imaging, II Sep-30-2016
33 Philips Electronics North America Corporation II Oct-13-2017
34 Philips Electronics North America Corporation II Nov-22-2016
35 Philips Electronics North America Corporation II Dec-12-2015
36 Philips Healthcare II Jun-06-2016
37 Philips Medical Systems II Oct-04-2016
38 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
39 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
40 Philips Medical Systems (Cleveland) Inc II Nov-30-2018
41 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
42 Philips Medical Systems (Cleveland) Inc II Jul-02-2018
43 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
44 Philips Medical Systems (Cleveland) Inc II Jun-12-2018
45 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
46 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
47 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
48 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
49 Philips Medical Systems (Cleveland) Inc II Feb-09-2018
50 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
51 Philips Medical Systems (Cleveland) Inc II Jan-23-2018
52 Philips Medical Systems (Cleveland) Inc II Jan-19-2018
53 Philips Medical Systems (Cleveland) Inc II Jan-11-2018
54 Philips Medical Systems (Cleveland) Inc II Mar-20-2017
55 Philips Medical Systems (Cleveland) Inc II Jan-20-2017
56 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
57 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
58 Philips Medical Systems (Cleveland) Inc II Dec-02-2016
59 Philips Medical Systems (Cleveland) Inc III Nov-16-2016
60 Philips Medical Systems (Cleveland) Inc II Aug-25-2016
61 Philips Medical Systems (Cleveland) Inc II Aug-10-2016
62 Philips Medical Systems (Cleveland) Inc II Aug-09-2016
63 Philips Medical Systems (Cleveland) Inc II Aug-05-2016
64 Philips Medical Systems (Cleveland) Inc II Jul-01-2016
65 Philips Medical Systems (Cleveland) Inc II Jun-30-2016
66 Philips Medical Systems (Cleveland) Inc II Jun-30-2016
67 Philips Medical Systems (Cleveland) Inc II May-31-2016
68 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
69 Philips Medical Systems (Cleveland) Inc II Apr-08-2016
70 Philips Medical Systems (Cleveland) Inc II Dec-24-2015
71 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
72 Philips Medical Systems (Cleveland) Inc II Dec-10-2015
73 Philips Medical Systems (Cleveland) Inc II Nov-02-2015
74 Philips Medical Systems (Cleveland) Inc II Oct-30-2015
75 Philips Medical Systems (Cleveland) Inc II Jul-24-2015
76 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
77 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
78 Philips Medical Systems (Cleveland) Inc II May-29-2015
79 Philips Medical Systems (Cleveland) Inc II May-22-2015
80 Philips Medical Systems (Cleveland) Inc II Apr-01-2015
81 Philips Medical Systems (Cleveland) Inc II Jan-15-2015
82 Philips North America, LLC II May-06-2020
83 Philips and Neusoft Medical Systems Co., Ltd. II Apr-27-2016
84 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
85 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
86 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
87 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
88 Siemens Medical Solutions USA, Inc II Nov-21-2019
89 Siemens Medical Solutions USA, Inc II Nov-14-2019
90 Siemens Medical Solutions USA, Inc II Aug-30-2019
91 Siemens Medical Solutions USA, Inc II Aug-28-2019
92 Siemens Medical Solutions USA, Inc II Aug-14-2019
93 Siemens Medical Solutions USA, Inc II Jul-02-2019
94 Siemens Medical Solutions USA, Inc II Jul-02-2019
95 Siemens Medical Solutions USA, Inc II May-03-2019
96 Siemens Medical Solutions USA, Inc II Apr-09-2019
97 Siemens Medical Solutions USA, Inc II May-25-2018
98 Siemens Medical Solutions USA, Inc II May-15-2018
99 Siemens Medical Solutions USA, Inc II Apr-30-2018
100 Siemens Medical Solutions USA, Inc II Mar-30-2018
101 Siemens Medical Solutions USA, Inc II Feb-24-2018
102 Siemens Medical Solutions USA, Inc II Jun-21-2017
103 Siemens Medical Solutions USA, Inc II Dec-12-2016
104 Siemens Medical Solutions USA, Inc II Dec-02-2016
105 Siemens Medical Solutions USA, Inc II Nov-17-2016
106 Siemens Medical Solutions USA, Inc II Nov-17-2016
107 Siemens Medical Solutions USA, Inc II Nov-08-2016
108 Siemens Medical Solutions USA, Inc II Aug-23-2016
109 Siemens Medical Solutions USA, Inc II Apr-22-2016
110 Siemens Medical Solutions USA, Inc II Apr-19-2016
111 Siemens Medical Solutions USA, Inc II Apr-08-2016
112 Siemens Medical Solutions USA, Inc II Mar-31-2016
113 Siemens Medical Solutions USA, Inc II Oct-06-2015
114 Siemens Medical Solutions USA, Inc II Oct-05-2015
115 Siemens Medical Solutions USA, Inc II Jun-27-2015
116 Siemens Medical Solutions USA, Inc II May-22-2015
117 Siemens Medical Solutions USA, Inc II Mar-12-2015
118 Siemens Medical Solutions USA, Inc II Jan-14-2015
119 Siemens Medical Solutions USA, Inc. II Jun-08-2018
120 Siemens Medical Solutions USA, Inc. II May-02-2018
121 Siemens Medical Solutions USA, Inc. II Jan-21-2016
122 Toshiba American Medical Systems Inc II Nov-18-2016
123 Toshiba American Medical Systems Inc II Oct-06-2016
124 Toshiba American Medical Systems Inc II Apr-22-2016
125 Toshiba American Medical Systems Inc II Oct-09-2015
126 Xoran Technologies, Inc. II Jun-26-2015
127 Xoran Technologies, Inc. II Jun-26-2015
128 Xoran Technologies, Inc. II Jun-26-2015
129 Xoran Technologies, Inc. II Jun-26-2015
130 Xoran Technologies, Inc. II Jun-26-2015
131 Xoran Technologies, LLC II Mar-02-2015

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