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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 5
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 3
CURVEBEAM
  SUBSTANTIALLY EQUIVALENT 2
EDDA TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 6
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 36
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 33
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 364
Device Operates Differently Than Expected 118
Mechanical Problem 101
Use of Device Problem 44
Unintended System Motion 43
Detachment of Device or device Component 35
Device Operational Issue 30
Device Displays Incorrect Message 28
Detachment Of Device Component 26
Material Fragmentation 25
Signal Artifact 23
Improper or Incorrect Procedure or Method 22
Patient Data Problem 21
Unintended Movement 21
Application Network Problem 18
Computer Software Problem 17
Insufficient Information 16
Application Program Problem 15
Image Display Error / Artifact 13
Positioning Problem 12
Human-Device Interface Problem 11
Output Problem 10
Incorrect, Inadequate or Imprecise Result or Readings 10
Mechanical Jam 9
Programming Issue 9
Data Problem 8
Break 8
Connection Problem 8
Poor Quality Image 7
Calibration Problem 6
Material Deformation 6
Patient Device Interaction Problem 6
Device Handling Problem 5
Inadequate User Interface 5
Leak / Splash 5
Electrical /Electronic Property Problem 5
Overheating of Device 4
Communication or Transmission Problem 4
Device Stops Intermittently 4
Improper Device Output 4
Power Problem 3
Application Program Freezes, Becomes Nonfunctional 3
Defective Device 3
Installation-Related Problem 3
Sticking 3
Material Integrity Problem 3
Program or Algorithm Execution Problem 3
Display or Visual Feedback Problem 3
No Display / Image 3
Radiofrequency Interference (RFI) 3
Thermal Decomposition of Device 2
Unintended Collision 2
Disconnection 2
Incorrect Or Inadequate Test Results 2
Malposition of device 2
Loose or Intermittent Connection 2
Device Inoperable 2
Mechanics Altered 2
Activation, Positioning or Separation Problem 2
Fuse 2
Output above Specifications 2
Incorrect Measurement 2
Computer Operating System Problem 2
Difficult to Advance 2
Device Issue 2
Unintended Electrical Shock 2
Battery Problem 2
Smoking 2
Radiation Overexposure 2
Human Factors Issue 2
Device Abrasion From Instrument Or Another Object 1
Coagulation in Device or device Ingredient 1
Unintended Ejection 1
Wiring Harness 1
Electromagnetic Interference 1
Facilities Issue 1
Misconnection 1
Physical Property Issue 1
Motor 1
Volume Accuracy Problem 1
Gas Leak 1
Loss of Power 1
Operating System Becomes Nonfunctional 1
Device Alarm System 1
Circuit Board 1
Component or Accessory Incompatibility 1
Device Tipped Over 1
Device Dislodged or Dislocated 1
Component Falling 1
Device Fell 1
Failure to Power Up 1
PC (Printed Circuit) Board 1
Failure to Advance 1
Chemical Spillage 1
Device Misassembled During Manufacturing / Shipping 1
Device Slipped 1
Protective Measures Problem 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Device Maintenance Issue 1
Automatic Injection System 1
Total Device Problems 1226

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

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