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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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New Search show TPLC since Back to Search Results
Device system, x-ray, tomography, computed
Product CodeJAK
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
4DMEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
4DX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
AIDOC MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARINETA LTD.
  SUBSTANTIALLY EQUIVALENT 2
BUNKERHILL, INC
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 16
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
FLUIDDA INC.
  SUBSTANTIALLY EQUIVALENT 1
FMI MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS,LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISYS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEVIS MEDICAL SOLUTIONS AG
  SUBSTANTIALLY EQUIVALENT 1
NANO-X AI LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANOXAI LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION,
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 2
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM SURGICAL SAS
  SUBSTANTIALLY EQUIVALENT 2
SHANGAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 24
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THIRONA BV
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIDA DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
XACT ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
XACT ROBOTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 233 233
2020 177 177
2021 261 261
2022 199 200
2023 310 310
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 207 207
Application Program Problem 145 145
Device Displays Incorrect Message 87 87
Use of Device Problem 68 68
Patient Data Problem 60 60
Insufficient Information 52 52
Device Operational Issue 50 50
Break 46 46
Sharp Edges 45 45
Improper or Incorrect Procedure or Method 43 43
Computer Software Problem 41 41
Connection Problem 36 36
Unintended System Motion 29 29
Material Fragmentation 28 28
Image Display Error/Artifact 28 28
Retraction Problem 27 27
Display or Visual Feedback Problem 25 25
Material Separation 24 24
Communication or Transmission Problem 23 23
Defective Device 21 21
Application Network Problem 19 19
Application Program Freezes, Becomes Nonfunctional 18 18
Unexpected Shutdown 17 17
Detachment of Device or Device Component 16 16
Failure to Advance 15 15
Unintended Movement 15 15
Mechanical Problem 15 15
Output Problem 14 14
Device Sensing Problem 13 13
Electrical /Electronic Property Problem 13 13
No Display/Image 12 12
Therapeutic or Diagnostic Output Failure 12 12
No Apparent Adverse Event 12 12
Device Handling Problem 12 12
Unintended Electrical Shock 10 10
Defective Component 9 9
Poor Quality Image 9 9
Failure to Power Up 8 8
Radiofrequency Interference (RFI) 8 8
Data Problem 8 8
Material Twisted/Bent 8 8
Device Dislodged or Dislocated 7 7
Program or Algorithm Execution Problem 7 7
Intermittent Program or Algorithm Execution 7 7
Program or Algorithm Execution Failure 6 6
Activation, Positioning or Separation Problem 6 6
Power Problem 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 5 5
Inadequate or Insufficient Training 5 5
Unintended Collision 5 5
Erratic or Intermittent Display 5 5
Loose or Intermittent Connection 5 5
Migration or Expulsion of Device 4 4
Fire 4 4
Positioning Failure 4 4
Use of Incorrect Control/Treatment Settings 4 4
Loss of Power 4 4
Unstable 4 4
Protective Measures Problem 4 4
Radiation Overexposure 4 4
Positioning Problem 4 4
Material Integrity Problem 4 4
Calibration Problem 4 4
Unintended Application Program Shut Down 4 4
Battery Problem 3 3
Computer Operating System Problem 3 3
Arcing 3 3
Device Markings/Labelling Problem 3 3
Operating System Becomes Nonfunctional 3 3
Component Missing 3 3
No Device Output 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Crack 3 3
Device Alarm System 3 3
Circuit Failure 3 3
Entrapment of Device 3 3
Image Orientation Incorrect 3 3
Imprecision 2 2
Application Program Problem: Dose Calculation Error 2 2
Fluid/Blood Leak 2 2
Display Difficult to Read 2 2
Unintended Power Up 2 2
Signal Artifact/Noise 2 2
Product Quality Problem 2 2
Premature Activation 2 2
Smoking 2 2
Device Damaged Prior to Use 2 2
Failure to Calibrate 2 2
Structural Problem 2 2
Mechanical Jam 2 2
Noise, Audible 2 2
Device Fell 2 2
Loss of Data 2 2
Installation-Related Problem 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Gas/Air Leak 2 2
Human-Device Interface Problem 2 2
Delayed Program or Algorithm Execution 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 388 388
Pneumothorax 121 121
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
No Code Available 103 103
Insufficient Information 77 77
No Known Impact Or Consequence To Patient 60 60
Laceration(s) 50 50
Radiation Exposure, Unintended 44 44
No Consequences Or Impact To Patient 35 35
Unintended Radiation Exposure 31 31
Hemorrhage/Bleeding 26 26
Bone Fracture(s) 22 22
Abrasion 20 20
Blood Loss 18 18
Injury 13 13
Death 12 12
Cardiac Arrest 11 11
Bruise/Contusion 10 10
Electric Shock 10 10
No Patient Involvement 10 10
Limb Fracture 10 10
Foreign Body In Patient 9 9
Unspecified Tissue Injury 9 9
Patient Problem/Medical Problem 8 8
Chest Pain 8 8
Head Injury 8 8
Headache 7 7
No Information 7 7
Skin Tears 6 6
Respiratory Failure 6 6
Misdiagnosis 5 5
Nausea 4 4
Burning Sensation 4 4
Hypersensitivity/Allergic reaction 4 4
Dyspnea 4 4
Pain 4 4
Crushing Injury 4 4
Tachycardia 3 3
Fatigue 3 3
Cough 3 3
Not Applicable 3 3
Brain Injury 2 2
Hemoptysis 2 2
Respiratory Arrest 2 2
Confusion/ Disorientation 2 2
Cyst(s) 2 2
Hip Fracture 2 2
Muscle Weakness 2 2
Airway Obstruction 2 2
Hemorrhagic Stroke 2 2
Rash 2 2
Oversedation 2 2
Fever 2 2
Dizziness 2 2
Vomiting 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Blurred Vision 2 2
Tinnitus 1 1
Damage to Ligament(s) 1 1
Apnea 1 1
Syncope/Fainting 1 1
Anaphylactic Shock 1 1
Hallucination 1 1
Weight Changes 1 1
Missing Value Reason 1 1
Unspecified Nervous System Problem 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Loss of Vision 1 1
Pulmonary Edema 1 1
Fasciitis 1 1
Neuralgia 1 1
Diaphoresis 1 1
Loss of consciousness 1 1
Bronchial Hemorrhage 1 1
Fall 1 1
Dry Eye(s) 1 1
Glossitis 1 1
Unspecified Reproductive System or Breast Problem 1 1
Viral Infection 1 1
Hematoma 1 1
Solid Tumour 1 1
Suture Abrasion 1 1
Pneumonia 1 1
Fracture, Arm 1 1
Rupture 1 1
Ambulation Difficulties 1 1
Cancer 1 1
Numbness 1 1
Erythema 1 1
Sweating 1 1
Cognitive Changes 1 1
Memory Loss/Impairment 1 1
Unspecified Gastrointestinal Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Weakness 1 1
Fibrosis 1 1
Respiratory Distress 1 1
Ventilator Dependent 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Dec-09-2020
2 Canon Medical System, USA, INC. II Apr-10-2020
3 Carestream Health, Inc. II Apr-23-2019
4 Covidien, LLC II Jun-26-2023
5 FUJIFILM Healthcare Americas Corporation II Sep-16-2022
6 GE Healthcare, LLC II Apr-05-2022
7 GE Healthcare, LLC II Nov-24-2021
8 GE Healthcare, LLC II Jul-08-2021
9 GE Healthcare, LLC II Jul-08-2021
10 GE Healthcare, LLC II Jun-25-2021
11 GE Healthcare, LLC II Feb-17-2021
12 GE Healthcare, LLC II Dec-22-2020
13 GE Healthcare, LLC II Oct-29-2020
14 GE Healthcare, LLC II Jul-12-2019
15 GE Healthcare, LLC II May-03-2019
16 GE Healthcare, LLC II Feb-06-2019
17 Hitachi Medical Systems America Inc II Nov-01-2019
18 Imactis II Mar-16-2021
19 Imactis II Sep-15-2020
20 Imactis II Jan-22-2020
21 Mobius Imaging, LLC II Jan-17-2023
22 Mobius Imaging, LLC II Dec-06-2022
23 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
24 NeuroLogica Corporation II Jul-03-2023
25 NeuroLogica Corporation II Aug-07-2020
26 Neusoft Medical Systems Co., Ltd. II May-21-2019
27 Olympus Corporation of the Americas II Sep-29-2023
28 Olympus Corporation of the Americas II Jul-28-2023
29 Olympus Corporation of the Americas II Feb-07-2023
30 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
31 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
32 Philips Healthcare II Sep-30-2023
33 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
34 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
35 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
36 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
37 Philips North America, LLC II May-06-2020
38 Philips North America II Jan-12-2024
39 Philips North America II Nov-16-2023
40 Philips North America II Nov-15-2023
41 Philips North America II Jul-28-2023
42 Philips North America II May-12-2023
43 Philips North America Llc II Jan-12-2024
44 Philips North America Llc II Dec-18-2023
45 Philips North America Llc II Nov-14-2023
46 Philips North America Llc II May-12-2023
47 Philips North America Llc II Nov-24-2021
48 Philips North America Llc II Aug-18-2021
49 Philips North America Llc II Jun-30-2021
50 Philips North America Llc II Jun-02-2021
51 Philips North America Llc II Mar-16-2021
52 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
53 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
54 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
55 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
56 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
57 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
58 Siemens Medical Solutions USA, Inc II Jan-20-2023
59 Siemens Medical Solutions USA, Inc II Aug-26-2022
60 Siemens Medical Solutions USA, Inc II Jul-06-2022
61 Siemens Medical Solutions USA, Inc II Apr-22-2022
62 Siemens Medical Solutions USA, Inc II Apr-20-2022
63 Siemens Medical Solutions USA, Inc II Jan-10-2022
64 Siemens Medical Solutions USA, Inc II Nov-24-2021
65 Siemens Medical Solutions USA, Inc II Sep-21-2021
66 Siemens Medical Solutions USA, Inc II Sep-10-2021
67 Siemens Medical Solutions USA, Inc II Mar-15-2021
68 Siemens Medical Solutions USA, Inc II Jan-09-2021
69 Siemens Medical Solutions USA, Inc II Sep-28-2020
70 Siemens Medical Solutions USA, Inc II Nov-21-2019
71 Siemens Medical Solutions USA, Inc II Nov-14-2019
72 Siemens Medical Solutions USA, Inc II Aug-30-2019
73 Siemens Medical Solutions USA, Inc II Aug-28-2019
74 Siemens Medical Solutions USA, Inc II Aug-14-2019
75 Siemens Medical Solutions USA, Inc II Jul-02-2019
76 Siemens Medical Solutions USA, Inc II Jul-02-2019
77 Siemens Medical Solutions USA, Inc II May-03-2019
78 Siemens Medical Solutions USA, Inc II Apr-09-2019
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