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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, tomography, computed, emission
Product CodeKPS
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
BRACCO DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
COMBINOSTICS OY
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 3
MCGOVERN MEDICAL SCHOOL
  SUBSTANTIALLY EQUIVALENT 2
MIEGMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 2
PRESCIENT IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIALIS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 9
SIRTEX MEDICAL US HOLDINGS INC.
  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 2

MDR Year MDR Reports MDR Events
2018 26 26
2019 105 105
2020 22 22
2021 10 10
2022 15 15
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 34 34
Misassembled During Installation 30 30
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Unintended Movement 11 11
Self-Activation or Keying 9 9
Fail-Safe Problem 8 8
Unintended Collision 6 6
Mechanical Problem 5 5
Crack 5 5
Difficult to Open or Close 5 5
Device Operates Differently Than Expected 4 4
Signal Artifact/Noise 4 4
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 3 3
Positioning Problem 3 3
Degraded 3 3
Detachment of Device or Device Component 3 3
Failure to Read Input Signal 3 3
Defective Device 3 3
Device Displays Incorrect Message 2 2
Computer Operating System Problem 2 2
Loss of Data 2 2
Break 2 2
Component Falling 2 2
Leak/Splash 2 2
Failure to Shut Off 2 2
Insufficient Information 2 2
Noise, Audible 2 2
Device Fell 2 2
Radiation Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Loose or Intermittent Connection 1 1
Entrapment of Device 1 1
Fire 1 1
Fracture 1 1
Poor Quality Image 1 1
No Audible Alarm 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1
Activation, Positioning or Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Auto Stop 1 1
Malposition of Device 1 1
Application Program Version or Upgrade Problem 1 1
Smoking 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 70 70
No Patient Involvement 41 41
No Clinical Signs, Symptoms or Conditions 24 24
Laceration(s) 12 12
No Consequences Or Impact To Patient 12 12
Injury 11 11
Bone Fracture(s) 6 6
Insufficient Information 6 6
Head Injury 4 4
Fracture, Arm 3 3
Crushing Injury 2 2
Fall 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Unspecified Gastrointestinal Problem 1 1
Stroke/CVA 1 1
Renal Failure 1 1
Tissue Damage 1 1
Misdiagnosis 1 1
Concussion 1 1
Irritation 1 1
Electric Shock 1 1
Hip Fracture 1 1
Hernia 1 1
Physical Entrapment 1 1
Damage to Ligament(s) 1 1
Nerve Damage 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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING I Feb-08-2023
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 North America Llc II Nov-24-2021
23 Philips North America Llc II Jun-30-2021
24 Shanghai United Imaging Healthcare Co., Ltd. II Apr-07-2023
25 Shanghai United Imaging Healthcare Co., Ltd. II Oct-13-2022
26 Shanghai United Imaging Healthcare Co., Ltd. II Sep-29-2021
27 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
28 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
29 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
30 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
31 Siemens Medical Solutions USA, Inc. II Jul-28-2023
32 Siemens Medical Solutions USA, Inc. II Feb-13-2023
33 Siemens Medical Solutions USA, Inc. II Apr-07-2022
34 Siemens Medical Solutions USA, Inc. II Sep-02-2020
35 Siemens Medical Solutions USA, Inc. II Aug-27-2020
36 Siemens Medical Solutions USA, Inc. II Jan-10-2019
37 Siemens Medical Solutions USA, Inc. II Nov-02-2018
38 Siemens Medical Solutions USA, Inc. II Oct-18-2018
39 Siemens Medical Solutions USA, Inc. II May-24-2018
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