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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
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COMBINOSTICS OY
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 3
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
POSITRIGO AG
  SUBSTANTIALLY EQUIVALENT 1
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 6
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SIRTEX MEDICAL US HOLDINGS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTERMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 105 105
2020 22 22
2021 10 10
2022 15 15
2023 22 22
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 38 38
Misassembled During Installation 30 30
Use of Device Problem 19 19
Improper or Incorrect Procedure or Method 18 18
Unintended Movement 10 10
Self-Activation or Keying 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Fail-Safe Problem 8 8
Unintended Collision 6 6
Difficult to Open or Close 5 5
No Apparent Adverse Event 4 4
Mechanical Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Read Input Signal 3 3
Output Problem 3 3
Crack 3 3
Insufficient Information 3 3
Smoking 3 3
Defective Device 3 3
Loss of Data 2 2
Device Dislodged or Dislocated 2 2
Detachment of Device or Device Component 2 2
Device Handling Problem 2 2
Computer Operating System Problem 2 2
Positioning Problem 2 2
Device Fell 2 2
Failure to Shut Off 2 2
Leak/Splash 2 2
Problem with Software Installation 1 1
Failure to Power Up 1 1
Application Program Version or Upgrade Problem 1 1
Structural Problem 1 1
Failure to Auto Stop 1 1
Poor Quality Image 1 1
Malposition of Device 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Fire 1 1
Entrapment of Device 1 1
Break 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Radiation Output Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Remains Activated 1 1
Device Displays Incorrect Message 1 1
Signal Artifact/Noise 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 55 55
No Patient Involvement 40 40
No Clinical Signs, Symptoms or Conditions 33 33
Laceration(s) 17 17
Bone Fracture(s) 12 12
No Consequences Or Impact To Patient 12 12
Injury 8 8
Insufficient Information 7 7
Head Injury 4 4
Crushing Injury 4 4
Fall 3 3
Fracture, Arm 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pain 2 2
Damage to Ligament(s) 1 1
Stroke/CVA 1 1
Hip Fracture 1 1
Electric Shock 1 1
Radiation Exposure, Unintended 1 1
Unspecified Gastrointestinal Problem 1 1
Misdiagnosis 1 1
Hematoma 1 1
Irritation 1 1
Nerve Damage 1 1
Concussion 1 1
Hernia 1 1
Physical Entrapment 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Nov-01-2024
2 Canon Medical System, USA, INC. II Oct-19-2021
3 GE Healthcare, LLC II May-11-2021
4 GE Healthcare, LLC II Jan-13-2021
5 GE Healthcare, LLC II Sep-21-2020
6 GE Healthcare, LLC II Jun-03-2020
7 GE Healthcare, LLC II Jun-19-2019
8 GE Healthcare, LLC II Jan-09-2019
9 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING II Jun-07-2024
10 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING I Feb-08-2023
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 North America I Feb-02-2024
16 Philips North America II Jan-05-2024
17 Philips North America Llc II Nov-24-2021
18 Philips North America Llc II Jun-30-2021
19 Shanghai United Imaging Healthcare Co., Ltd. II Apr-07-2023
20 Shanghai United Imaging Healthcare Co., Ltd. II Oct-13-2022
21 Shanghai United Imaging Healthcare Co., Ltd. II Sep-29-2021
22 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
23 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
24 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
25 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
26 Siemens Medical Solutions USA, Inc. II Jul-28-2023
27 Siemens Medical Solutions USA, Inc. II Feb-13-2023
28 Siemens Medical Solutions USA, Inc. II Apr-07-2022
29 Siemens Medical Solutions USA, Inc. II Sep-02-2020
30 Siemens Medical Solutions USA, Inc. II Aug-27-2020
31 Siemens Medical Solutions USA, Inc. II Jan-10-2019
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