Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, 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 17
CASCINATION AG
  SUBSTANTIALLY EQUIVALENT 1
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 HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 5
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 2
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 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 26
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 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 216 216
Application Program Problem 148 148
Device Displays Incorrect Message 95 95
Use of Device Problem 69 69
Patient Data Problem 61 61
Insufficient Information 55 55
Device Operational Issue 50 50
Break 46 46
Improper or Incorrect Procedure or Method 45 45
Sharp Edges 45 45
Computer Software Problem 41 41
Connection Problem 36 36
Unintended System Motion 30 30
Material Fragmentation 28 28
Image Display Error/Artifact 28 28
Retraction Problem 27 27
Display or Visual Feedback Problem 25 25
Communication or Transmission Problem 25 25
Material Separation 24 24
Defective Device 21 21
Application Network Problem 20 20
Detachment of Device or Device Component 18 18
Application Program Freezes, Becomes Nonfunctional 18 18
Unexpected Shutdown 17 17
Unintended Movement 16 16
Failure to Advance 15 15
Mechanical Problem 15 15
No Apparent Adverse Event 14 14
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
Device Handling Problem 12 12
Unintended Electrical Shock 11 11
Radiofrequency Interference (RFI) 10 10
Failure to Power Up 10 10
Poor Quality Image 9 9
Defective Component 9 9
Material Twisted/Bent 9 9
Data Problem 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 7 7
Appropriate Term/Code Not Available 6 6
Activation, Positioning or Separation Problem 6 6
Power Problem 5 5
Patient Device Interaction Problem 5 5
Material Integrity 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
Calibration Problem 4 4
Protective Measures Problem 4 4
Radiation Overexposure 4 4
Positioning Problem 4 4
Unintended Application Program Shut Down 4 4
Mechanical Jam 3 3
Operating System Becomes Nonfunctional 3 3
Battery Problem 3 3
Computer Operating System Problem 3 3
Arcing 3 3
Device Markings/Labelling Problem 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
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
Noise, Audible 2 2
Device Fell 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 408 408
Pneumothorax 121 121
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 108 108
No Code Available 103 103
Insufficient Information 81 81
No Known Impact Or Consequence To Patient 60 60
Laceration(s) 51 51
Radiation Exposure, Unintended 44 44
No Consequences Or Impact To Patient 35 35
Unintended Radiation Exposure 33 33
Hemorrhage/Bleeding 29 29
Bone Fracture(s) 24 24
Abrasion 20 20
Blood Loss 18 18
Injury 13 13
Death 12 12
Cardiac Arrest 11 11
Limb Fracture 11 11
No Patient Involvement 10 10
Electric Shock 10 10
Bruise/Contusion 10 10
Head Injury 9 9
Foreign Body In Patient 9 9
Unspecified Tissue Injury 9 9
Patient Problem/Medical Problem 8 8
Chest Pain 8 8
Headache 7 7
No Information 7 7
Skin Tears 6 6
Respiratory Failure 6 6
Misdiagnosis 5 5
Burning Sensation 4 4
Nausea 4 4
Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Crushing Injury 4 4
Dyspnea 4 4
Hemoptysis 3 3
Fatigue 3 3
Tachycardia 3 3
Not Applicable 3 3
Cough 3 3
Respiratory Arrest 2 2
Muscle/Tendon Damage 2 2
Hemorrhagic Stroke 2 2
Brain Injury 2 2
Confusion/ Disorientation 2 2
Rash 2 2
Oversedation 2 2
Muscle Weakness 2 2
Dizziness 2 2
Blurred Vision 2 2
Vomiting 2 2
Hip Fracture 2 2
Fever 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Cyst(s) 2 2
Airway Obstruction 2 2
Anaphylactic Shock 1 1
Apnea 1 1
Bradycardia 1 1
Burn(s) 1 1
Stroke/CVA 1 1
Contusion 1 1
Emotional Changes 1 1
Erythema 1 1
Eye Injury 1 1
Fall 1 1
Failure of Implant 1 1
Abdominal Pain 1 1
Intracranial Hemorrhage 1 1
Dry Eye(s) 1 1
Hearing Impairment 1 1
Hematoma 1 1
Fracture, Arm 1 1
Arthralgia 1 1
Malaise 1 1
Fasciitis 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1
Numbness 1 1
Coma 1 1
Loss of consciousness 1 1
Tooth Fracture 1 1
Sweating 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Weakness 1 1
Loss of Vision 1 1
Electrolyte Imbalance 1 1
Damage to Ligament(s) 1 1
Memory Loss/Impairment 1 1
Perforation 1 1
Pneumonia 1 1
Pulmonary Edema 1 1
Loss of Range of Motion 1 1
Respiratory Distress 1 1
Sepsis 1 1
Shock 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 Apr-09-2024
39 Philips North America II Jan-12-2024
40 Philips North America II Nov-16-2023
41 Philips North America II Nov-15-2023
42 Philips North America II Jul-28-2023
43 Philips North America II May-12-2023
44 Philips North America Llc II Jan-12-2024
45 Philips North America Llc II Dec-18-2023
46 Philips North America Llc II Nov-14-2023
47 Philips North America Llc II May-12-2023
48 Philips North America Llc II Nov-24-2021
49 Philips North America Llc II Aug-18-2021
50 Philips North America Llc II Jun-30-2021
51 Philips North America Llc II Jun-02-2021
52 Philips North America Llc II Mar-16-2021
53 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
54 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
55 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
56 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
57 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
58 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
59 Siemens Medical Solutions USA, Inc II Jan-20-2023
60 Siemens Medical Solutions USA, Inc II Aug-26-2022
61 Siemens Medical Solutions USA, Inc II Jul-06-2022
62 Siemens Medical Solutions USA, Inc II Apr-22-2022
63 Siemens Medical Solutions USA, Inc II Apr-20-2022
64 Siemens Medical Solutions USA, Inc II Jan-10-2022
65 Siemens Medical Solutions USA, Inc II Nov-24-2021
66 Siemens Medical Solutions USA, Inc II Sep-21-2021
67 Siemens Medical Solutions USA, Inc II Sep-10-2021
68 Siemens Medical Solutions USA, Inc II Mar-15-2021
69 Siemens Medical Solutions USA, Inc II Jan-09-2021
70 Siemens Medical Solutions USA, Inc II Sep-28-2020
71 Siemens Medical Solutions USA, Inc II Nov-21-2019
72 Siemens Medical Solutions USA, Inc II Nov-14-2019
73 Siemens Medical Solutions USA, Inc II Aug-30-2019
74 Siemens Medical Solutions USA, Inc II Aug-28-2019
75 Siemens Medical Solutions USA, Inc II Aug-14-2019
76 Siemens Medical Solutions USA, Inc II Jul-02-2019
77 Siemens Medical Solutions USA, Inc II Jul-02-2019
78 Siemens Medical Solutions USA, Inc II May-03-2019
79 Siemens Medical Solutions USA, Inc II Apr-09-2019
-
-