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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 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 2
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 2
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 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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 36 36
Misassembled During Installation 30 30
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 14 14
Unintended Movement 10 10
Self-Activation or Keying 9 9
Fail-Safe Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Unintended Collision 6 6
Difficult to Open or Close 5 5
Mechanical Problem 4 4
No Apparent Adverse Event 4 4
Therapeutic or Diagnostic Output Failure 4 4
Crack 3 3
Failure to Read Input Signal 3 3
Defective Device 3 3
Output Problem 3 3
Positioning Problem 2 2
Detachment of Device or Device Component 2 2
Failure to Shut Off 2 2
Computer Operating System Problem 2 2
Loss of Data 2 2
Leak/Splash 2 2
Device Fell 2 2
Insufficient Information 2 2
Device Handling Problem 1 1
Noise, Audible 1 1
Radiation Output Problem 1 1
Poor Quality Image 1 1
Entrapment of Device 1 1
Fire 1 1
Signal Artifact/Noise 1 1
Break 1 1
Smoking 1 1
Structural Problem 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
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Application Program Version or Upgrade Problem 1 1
Failure to Auto Stop 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 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 28 28
Laceration(s) 12 12
No Consequences Or Impact To Patient 12 12
Injury 8 8
Bone Fracture(s) 7 7
Insufficient Information 6 6
Head Injury 4 4
Crushing Injury 3 3
Fall 3 3
Fracture, Arm 2 2
Patient Problem/Medical Problem 2 2
Radiation Exposure, Unintended 1 1
Unspecified Gastrointestinal Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Stroke/CVA 1 1
Electric Shock 1 1
Hip Fracture 1 1
Hernia 1 1
Physical Entrapment 1 1
Hematoma 1 1
Irritation 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Pain 1 1
Tissue Damage 1 1
Misdiagnosis 1 1
Concussion 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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING I Feb-08-2023
9 Philips Medical Systems (Cleveland) Inc I Nov-01-2019
10 Philips Medical Systems (Cleveland) Inc II Jul-22-2019
11 Philips Medical Systems (Cleveland) Inc II Jul-03-2019
12 Philips Medical Systems (Cleveland) Inc II Feb-12-2019
13 Philips North America I Feb-02-2024
14 Philips North America II Jan-05-2024
15 Philips North America Llc II Nov-24-2021
16 Philips North America Llc II Jun-30-2021
17 Shanghai United Imaging Healthcare Co., Ltd. II Apr-07-2023
18 Shanghai United Imaging Healthcare Co., Ltd. II Oct-13-2022
19 Shanghai United Imaging Healthcare Co., Ltd. II Sep-29-2021
20 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
21 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
22 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
23 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
24 Siemens Medical Solutions USA, Inc. II Jul-28-2023
25 Siemens Medical Solutions USA, Inc. II Feb-13-2023
26 Siemens Medical Solutions USA, Inc. II Apr-07-2022
27 Siemens Medical Solutions USA, Inc. II Sep-02-2020
28 Siemens Medical Solutions USA, Inc. II Aug-27-2020
29 Siemens Medical Solutions USA, Inc. II Jan-10-2019
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