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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 DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL EQUIPMENT FOR MEDICAL IMAGING
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 6
HERMES MEDICAL SOLUTIONS, AB
  SUBSTANTIALLY EQUIVALENT 1
MCGOVERN MEDICAL SCHOOL
  SUBSTANTIALLY EQUIVALENT 1
MIEGMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 2
PRESCIENT IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIRTEX MEDICAL US HOLDINGS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
SPECTRUM DYNAMICS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNTERMED
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON, TEXAS
  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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 32 32
Misassembled During Installation 30 30
Use of Device Problem 17 17
Adverse Event Without Identified Device or Use Problem 15 15
Improper or Incorrect Procedure or Method 13 13
Unintended Movement 12 12
Device Operates Differently Than Expected 12 12
Self-Activation or Keying 9 9
Mechanical Problem 8 8
Positioning Problem 6 6
Break 5 5
Crack 5 5
Difficult to Open or Close 5 5
Computer Operating System Problem 4 4
Degraded 4 4
Signal Artifact/Noise 4 4
Unintended Collision 4 4
Component Falling 3 3
Failure to Read Input Signal 3 3
Defective Device 3 3
Noise, Audible 3 3
Therapeutic or Diagnostic Output Failure 3 3
Fracture 2 2
Detachment of Device or Device Component 2 2
Failure to Shut Off 2 2
Output Problem 2 2
Device Tipped Over 2 2
Component Missing 2 2
Device Fell 2 2
Entrapment of Device 2 2
Device Displays Incorrect Message 2 2
Material Deformation 1 1
Mechanics Altered 1 1
Power Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Loose or Intermittent Connection 1 1
Poor Quality Image 1 1
Detachment Of Device Component 1 1
Device Remains Activated 1 1
Structural Problem 1 1
No Audible Alarm 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1
Display or Visual Feedback Problem 1 1
Fire 1 1
Device Emits Odor 1 1
Failure to Power Up 1 1
Device Slipped 1 1
Smoking 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Failure to Auto Stop 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
No Clinical Signs, Symptoms or Conditions 6 6
Fall 4 4
Head Injury 4 4
Fracture, Arm 3 3
Insufficient Information 3 3
Physical Entrapment 2 2
Crushing Injury 2 2
Contusion 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
Radiation Exposure, Unintended 1 1
No Information 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Electric Shock 1 1
Diarrhea 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Nerve Damage 1 1
Cataract 1 1
Hernia 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Irritation 1 1
Renal Failure 1 1
Misdiagnosis 1 1
Concussion 1 1
Hip Fracture 1 1

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