• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CEDARS-SINAI MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 6
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
RADIALIS INC.
  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 9
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIRTEX MEDICAL US HOLDINGS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
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
2017 31 31
2018 26 26
2019 105 105
2020 22 22
2021 10 10
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 33 33
Misassembled During Installation 30 30
Use of Device Problem 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Unintended Movement 12 12
Improper or Incorrect Procedure or Method 12 12
Device Operates Differently Than Expected 11 11
Self-Activation or Keying 9 9
Mechanical Problem 7 7
Positioning Problem 6 6
Difficult to Open or Close 5 5
Break 5 5
Crack 5 5
Degraded 4 4
Signal Artifact/Noise 4 4
Unintended Collision 4 4
Component Falling 3 3
Defective Device 3 3
Failure to Read Input Signal 3 3
Computer Operating System Problem 3 3
Noise, Audible 3 3
Therapeutic or Diagnostic Output Failure 3 3
Detachment of Device or Device Component 2 2
Output Problem 2 2
Device Fell 2 2
Failure to Shut Off 2 2
Device Tipped Over 2 2
Device Displays Incorrect Message 2 2
Component Missing 2 2
Structural Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Power Up 1 1
Device Remains Activated 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Smoking 1 1
Poor Quality Image 1 1
No Audible Alarm 1 1
Detachment Of Device Component 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Fire 1 1
Fracture 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Failure to Auto Stop 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Protective Measures Problem 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 82 82
No Patient Involvement 41 41
Injury 16 16
No Consequences Or Impact To Patient 14 14
Laceration(s) 13 13
Bone Fracture(s) 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Head Injury 4 4
Fall 3 3
Insufficient Information 3 3
Fracture, Arm 3 3
Patient Problem/Medical Problem 2 2
Crushing Injury 2 2
Pain 2 2
Renal Failure 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Misdiagnosis 1 1
Concussion 1 1
Nerve Damage 1 1
Hernia 1 1
Physical Entrapment 1 1
Cataract 1 1
Contusion 1 1
Intracranial Hemorrhage 1 1
Irritation 1 1
Electric Shock 1 1
Hip Fracture 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Unspecified Gastrointestinal Problem 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 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 Medical Systems (Cleveland) Inc II Apr-06-2017
23 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
24 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
25 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
26 Philips North America Llc II Nov-24-2021
27 Philips North America Llc II Jun-30-2021
28 Shanghai United Imaging Healthcare Co., Ltd. II Sep-29-2021
29 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
30 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
31 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
32 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
33 Siemens Medical Solutions USA Inc. II Feb-28-2017
34 Siemens Medical Solutions USA Inc. II Jan-10-2017
35 Siemens Medical Solutions USA, Inc. II Apr-07-2022
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
-
-