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


Premarket Reviews
ManufacturerDecision
BRACCO
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
CEDARS-SINAI MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 1
DDD-DIAGNOSTIC A/S
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 4
HERMES MEDICAL SOLUTIONS, AB
  SUBSTANTIALLY EQUIVALENT 1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 24 24
2016 10 10
2017 31 31
2018 26 26
2019 105 105
2020 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembled During Installation 30 30
Unintended System Motion 23 23
Improper or Incorrect Procedure or Method 17 17
Device Operates Differently Than Expected 16 16
Use of Device Problem 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Unintended Movement 14 14
Mechanical Problem 13 13
Self-Activation or Keying 9 9
Positioning Problem 6 6
Unintended Collision 6 6
Break 6 6
Insufficient Information 6 6
Crack 5 5
Degraded 5 5
Component Falling 5 5
Signal Artifact/Noise 4 4
Difficult to Open or Close 4 4
Computer Operating System Problem 4 4
Defective Device 3 3
Appropriate Term/Code Not Available 3 3
Controller 3 3
Noise, Audible 3 3
Failure to Read Input Signal 3 3
Switch, Push Button 2 2
Device Fell 2 2
Entrapment of Device 2 2
Collimator 2 2
Cover 2 2
Detector 2 2
Fracture 2 2
Ring 2 2
Component Missing 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Shut Off 2 2
Output Problem 2 2
Device Tipped Over 2 2
Activation, Positioning or SeparationProblem 2 2
Detachment of Device or Device Component 1 1
Failure to Auto Stop 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
Camera 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Device Slipped 1 1
Smoking 1 1
No Audible Alarm 1 1
Keypad 1 1
Display or Visual Feedback Problem 1 1
Fire 1 1
Housing 1 1
Microphone 1 1
Detachment Of Device Component 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Sensor 1 1
Device Remains Activated 1 1
Device Displays Incorrect Message 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Unit 1 1
Power Problem 1 1
Inadequate Service 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 85 85
No Patient Involvement 40 40
Injury 20 20
Bone Fracture(s) 19 19
No Consequences Or Impact To Patient 15 15
Laceration(s) 14 14
Physical Entrapment 5 5
Fracture, Arm 5 5
Head Injury 4 4
Bruise/Contusion 3 3
Pain 3 3
Fall 3 3
Crushing Injury 2 2
Patient Problem/Medical Problem 2 2
Contusion 2 2
Death 1 1
Diarrhea 1 1
Hemorrhage/Bleeding 1 1
Nerve Damage 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Electric Shock 1 1
Bacterial Infection 1 1
Cataract 1 1
Skin Tears 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Irritation 1 1
Renal Failure 1 1
Sprain 1 1
Misdiagnosis 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Sep-21-2015
2 GE Healthcare II Mar-13-2015
3 GE Healthcare, LLC II Sep-21-2020
4 GE Healthcare, LLC II Jun-03-2020
5 GE Healthcare, LLC II Jun-19-2019
6 GE Healthcare, LLC II Jan-09-2019
7 GE Healthcare, LLC II Dec-13-2018
8 GE Healthcare, LLC I Nov-14-2018
9 GE Healthcare, LLC II Jul-31-2018
10 GE Healthcare, LLC II Jun-12-2017
11 GE Medical Systems, LLC II Mar-04-2016
12 Philips Medical Systems (Cleveland) Inc I Nov-01-2019
13 Philips Medical Systems (Cleveland) Inc II Jul-22-2019
14 Philips Medical Systems (Cleveland) Inc II Jul-03-2019
15 Philips Medical Systems (Cleveland) Inc II Feb-12-2019
16 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
17 Philips Medical Systems (Cleveland) Inc II Jul-19-2018
18 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
19 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
20 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
21 Philips Medical Systems (Cleveland) Inc II Feb-03-2018
22 Philips Medical Systems (Cleveland) Inc II Apr-06-2017
23 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
24 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
25 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
26 Philips Medical Systems (Cleveland) Inc II Sep-03-2016
27 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
28 Philips Medical Systems (Cleveland) Inc II Feb-26-2016
29 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
30 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
31 Philips Medical Systems (Cleveland) Inc II May-28-2015
32 Philips Medical Systems (Cleveland) Inc II May-12-2015
33 Philips Medical Systems (Cleveland) Inc II Jan-26-2015
34 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
35 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
36 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
37 Siemens Medical Solutions USA Inc. II Feb-28-2017
38 Siemens Medical Solutions USA Inc. II Jan-10-2017
39 Siemens Medical Solutions USA Inc. II Jun-21-2016
40 Siemens Medical Solutions USA Inc. II Jun-15-2016
41 Siemens Medical Solutions USA Inc. II Aug-05-2015
42 Siemens Medical Solutions USA, Inc. II Sep-02-2020
43 Siemens Medical Solutions USA, Inc. II Aug-27-2020
44 Siemens Medical Solutions USA, Inc. II Jan-10-2019
45 Siemens Medical Solutions USA, Inc. II Nov-02-2018
46 Siemens Medical Solutions USA, Inc. II Oct-18-2018
47 Siemens Medical Solutions USA, Inc. II May-24-2018
48 Siemens Medical Solutions USA, Inc. II Nov-16-2017
49 Siemens Medical Solutions USA, Inc. II Oct-25-2017
50 Siemens Medical Solutions USA, Inc. II Oct-08-2016
51 Siemens Medical Solutions USA, Inc. II Mar-25-2016
52 Siemens Medical Solutions USA, Inc. II Nov-04-2015
53 Siemens Medical Solutions USA, Inc. II Aug-20-2015
54 Siemens Medical Solutions USA, Inc. II Mar-19-2015
55 Siemens Medical Solutions USA, Inc. II Feb-10-2015
56 Siemens Medical Solutions USA, Inc. II Jan-13-2015
57 Siemens Medical Solutions USA, Inc. II Jan-06-2015
58 Siemens Medical Solutions USA, Inc. II Jan-06-2015
59 Toshiba American Medical Systems Inc II Oct-06-2016
60 Toshiba American Medical Systems Inc II May-04-2016
61 Toshiba American Medical Systems Inc II Oct-07-2015
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