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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 2
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
CEDARS-SINAI MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 1
DDD-DIAGNOSTIC A/S
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 5
HERMES MEDICAL SOLUTIONS, AB
  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

MDR Year MDR Reports MDR Events
2016 10 10
2017 31 31
2018 26 26
2019 105 105
2020 22 22
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembled During Installation 30 30
Unintended System Motion 28 28
Use of Device Problem 16 16
Adverse Event Without Identified Device or Use Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Device Operates Differently Than Expected 12 12
Unintended Movement 12 12
Self-Activation or Keying 9 9
Mechanical Problem 8 8
Positioning Problem 6 6
Break 5 5
Crack 5 5
Degraded 4 4
Signal Artifact/Noise 4 4
Unintended Collision 4 4
Difficult to Open or Close 4 4
Computer Operating System Problem 4 4
Failure to Read Input Signal 3 3
Defective Device 3 3
Component Falling 3 3
Therapeutic or Diagnostic Output Failure 3 3
Noise, Audible 3 3
Device Fell 2 2
Detachment of Device or Device Component 2 2
Output Problem 2 2
Fracture 2 2
Entrapment of Device 2 2
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Component Missing 2 2
Failure to Shut Off 2 2
Material Deformation 1 1
Mechanics Altered 1 1
Failure to Auto Stop 1 1
Activation, Positioning or SeparationProblem 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1
Device Slipped 1 1
Smoking 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Fire 1 1
Display or Visual Feedback Problem 1 1
No Audible Alarm 1 1
Detachment Of Device Component 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 84 84
No Patient Involvement 41 41
Injury 18 18
No Consequences Or Impact To Patient 15 15
Bone Fracture(s) 14 14
Laceration(s) 10 10
Head Injury 4 4
Fall 3 3
Fracture, Arm 3 3
Physical Entrapment 2 2
Patient Problem/Medical Problem 2 2
Insufficient Information 2 2
Pain 2 2
Contusion 2 2
Crushing Injury 2 2
Diarrhea 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Cataract 1 1
Intracranial Hemorrhage 1 1
Irritation 1 1
Renal Failure 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Misdiagnosis 1 1
Concussion 1 1
Fever 1 1
Nerve Damage 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Jan-13-2021
2 GE Healthcare, LLC II Sep-21-2020
3 GE Healthcare, LLC II Jun-03-2020
4 GE Healthcare, LLC II Jun-19-2019
5 GE Healthcare, LLC II Jan-09-2019
6 GE Healthcare, LLC II Dec-13-2018
7 GE Healthcare, LLC I Nov-14-2018
8 GE Healthcare, LLC II Jul-31-2018
9 GE Healthcare, LLC II Jun-12-2017
10 GE Medical Systems, LLC II Mar-04-2016
11 Philips Medical Systems (Cleveland) Inc I Nov-01-2019
12 Philips Medical Systems (Cleveland) Inc II Jul-22-2019
13 Philips Medical Systems (Cleveland) Inc II Jul-03-2019
14 Philips Medical Systems (Cleveland) Inc II Feb-12-2019
15 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
16 Philips Medical Systems (Cleveland) Inc II Jul-19-2018
17 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
18 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
19 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
20 Philips Medical Systems (Cleveland) Inc II Feb-03-2018
21 Philips Medical Systems (Cleveland) Inc II Apr-06-2017
22 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
23 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
24 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
25 Philips Medical Systems (Cleveland) Inc II Sep-03-2016
26 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
27 Philips Medical Systems (Cleveland) Inc II Feb-26-2016
28 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
29 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
30 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
31 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
32 Siemens Medical Solutions USA Inc. II Feb-28-2017
33 Siemens Medical Solutions USA Inc. II Jan-10-2017
34 Siemens Medical Solutions USA Inc. II Jun-21-2016
35 Siemens Medical Solutions USA Inc. II Jun-15-2016
36 Siemens Medical Solutions USA, Inc. II Sep-02-2020
37 Siemens Medical Solutions USA, Inc. II Aug-27-2020
38 Siemens Medical Solutions USA, Inc. II Jan-10-2019
39 Siemens Medical Solutions USA, Inc. II Nov-02-2018
40 Siemens Medical Solutions USA, Inc. II Oct-18-2018
41 Siemens Medical Solutions USA, Inc. II May-24-2018
42 Siemens Medical Solutions USA, Inc. II Nov-16-2017
43 Siemens Medical Solutions USA, Inc. II Oct-25-2017
44 Siemens Medical Solutions USA, Inc. II Oct-08-2016
45 Siemens Medical Solutions USA, Inc. II Mar-25-2016
46 Toshiba American Medical Systems Inc II Oct-06-2016
47 Toshiba American Medical Systems Inc II May-04-2016
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