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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, tomography, computed
Product CodeJAK
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
4DX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
CANON MEDICAL SYSTEMS USA
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 3
FLUIDDA INC.
  SUBSTANTIALLY EQUIVALENT 1
FMI MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS,LLC
  SUBSTANTIALLY EQUIVALENT 1
GEF MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMACTIS, SAS
  SUBSTANTIALLY EQUIVALENT 1
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ISYS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
MASMEC SPA
  SUBSTANTIALLY EQUIVALENT 1
MOBIUS IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOXAI LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION,
  SUBSTANTIALLY EQUIVALENT 2
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 4
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
  SUBSTANTIALLY EQUIVALENT 2
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 INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC
  SUBSTANTIALLY EQUIVALENT 1
PHILLIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM SURGICAL SAS
  SUBSTANTIALLY EQUIVALENT 1
RIGHT DOSE INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 31
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THIRONA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS COROPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERAN MEDICAL TECHNOLOGIES, 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 2
ZETTA MEDICAL TECHNOLOGIES, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 337 337
2018 542 542
2019 233 233
2020 177 177
2021 261 261
2022 173 174

Device Problems MDRs with this Device Problem Events in those MDRs
Signal Artifact/Noise 365 365
Degraded 294 294
Adverse Event Without Identified Device or Use Problem 290 290
Application Program Problem 116 116
Device Operates Differently Than Expected 72 72
Device Operational Issue 65 65
Use of Device Problem 59 59
Device Displays Incorrect Message 49 49
Patient Data Problem 48 48
Sharp Edges 45 45
Break 42 42
Image Display Error/Artifact 41 41
Insufficient Information 41 41
Material Fragmentation 36 36
Improper or Incorrect Procedure or Method 36 36
No Audible Alarm 29 29
Device Inoperable 27 27
Computer Software Problem 26 26
Display or Visual Feedback Problem 26 26
Connection Problem 26 26
Mechanical Problem 24 24
Communication or Transmission Problem 22 22
Application Network Problem 22 22
Defective Device 18 18
Unintended Movement 18 18
Application Program Freezes, Becomes Nonfunctional 17 17
No Display/Image 16 16
Unintended System Motion 15 15
Failure to Advance 13 13
Unexpected Shutdown 13 13
Detachment of Device or Device Component 12 12
Poor Quality Image 12 12
Device Sensing Problem 11 11
Device Handling Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Human-Device Interface Problem 10 10
Defective Component 10 10
Electrical /Electronic Property Problem 10 10
Crack 9 9
Material Separation 9 9
Programming Issue 9 9
Output Problem 9 9
Loss of Power 8 8
Data Problem 8 8
Unintended Electrical Shock 8 8
Noise, Audible 7 7
Patient Device Interaction Problem 7 7
Failure to Power Up 7 7
Computer Operating System Problem 7 7
Radiofrequency Interference (RFI) 6 6
Material Deformation 6 6
Power Problem 6 6
Radiation Overexposure 6 6
Detachment Of Device Component 6 6
Appropriate Term/Code Not Available 6 6
Fire 5 5
No Apparent Adverse Event 5 5
Positioning Problem 5 5
Material Integrity Problem 5 5
Device Dislodged or Dislocated 5 5
Improper Device Output 4 4
Inadequate User Interface 4 4
Installation-Related Problem 4 4
Protective Measures Problem 4 4
Activation, Positioning or Separation Problem 4 4
Device Markings/Labelling Problem 4 4
Disconnection 4 4
Erratic or Intermittent Display 4 4
Loose or Intermittent Connection 4 4
Use of Incorrect Control/Treatment Settings 4 4
Migration or Expulsion of Device 4 4
Unintended Collision 4 4
Retraction Problem 4 4
Unstable 4 4
Inadequate or Insufficient Training 4 4
Unintended Application Program Shut Down 4 4
Program or Algorithm Execution Problem 4 4
Device Fell 3 3
Device Stops Intermittently 3 3
Smoking 3 3
Product Quality Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Component Falling 3 3
Positioning Failure 3 3
Device Alarm System 3 3
Thermal Decomposition of Device 3 3
Battery Problem 3 3
Calibration Problem 3 3
Component Missing 3 3
Physical Property Issue 3 3
Material Twisted/Bent 3 3
Mechanical Jam 3 3
Material Protrusion/Extrusion 2 2
Operating System Becomes Nonfunctional 2 2
Gas/Air Leak 2 2
Human Factors Issue 2 2
Electrical Shorting 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Device Damaged Prior to Use 2 2
Failure to Calibrate 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 581 581
No Clinical Signs, Symptoms or Conditions 170 170
Pneumothorax 150 150
No Code Available 115 115
No Consequences Or Impact To Patient 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Death 70 70
Radiation Exposure, Unintended 66 66
Laceration(s) 63 63
No Information 62 62
Insufficient Information 56 56
Blood Loss 35 35
Injury 34 34
Bone Fracture(s) 24 24
Unintended Radiation Exposure 22 22
No Patient Involvement 14 14
Hemorrhage/Bleeding 14 14
Abrasion 14 14
Cardiac Arrest 13 13
Bruise/Contusion 9 9
Head Injury 9 9
Electric Shock 8 8
Patient Problem/Medical Problem 8 8
Respiratory Failure 7 7
Chest Pain 7 7
Headache 6 6
Misdiagnosis 6 6
Pain 6 6
Limb Fracture 6 6
Skin Tears 5 5
Foreign Body In Patient 5 5
Physical Entrapment 4 4
Fracture, Arm 4 4
Unspecified Tissue Injury 4 4
Nausea 4 4
Fall 4 4
Crushing Injury 4 4
Burn(s) 4 4
Radiation Overdose 4 4
Fever 3 3
Hypoxia 3 3
Swelling 3 3
Tachycardia 3 3
Vomiting 3 3
Brain Injury 3 3
Cough 3 3
Not Applicable 3 3
Burning Sensation 3 3
Suture Abrasion 3 3
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Superficial (First Degree) Burn 2 2
Low Oxygen Saturation 2 2
Numbness 2 2
Loss of consciousness 2 2
Hip Fracture 2 2
Missing Value Reason 2 2
Cancer 2 2
Respiratory Arrest 2 2
Hemorrhagic Stroke 2 2
Dizziness 2 2
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Fatigue 2 2
Hearing Impairment 2 2
Bradycardia 2 2
Airway Obstruction 2 2
Stroke/CVA 2 2
Cardiopulmonary Arrest 1 1
Cyst(s) 1 1
Contusion 1 1
Apnea 1 1
Air Embolism 1 1
Radiation Burn 1 1
Hemoptysis 1 1
Intracranial Hemorrhage 1 1
Hemostasis 1 1
Hair Loss 1 1
Foreign Body Sensation in Eye 1 1
Dyspnea 1 1
Emotional Changes 1 1
Extravasation 1 1
Eye Injury 1 1
Irritation 1 1
Oversedation 1 1
Muscle Weakness 1 1
Tinnitus 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Rupture 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Hernia 1 1
Viral Infection 1 1
Weakness 1 1
Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bayer Medical Care, Inc. II Aug-31-2018
2 Brainlab AG II Feb-03-2018
3 Canon Medical System, USA, INC. II Dec-09-2020
4 Canon Medical System, USA, INC. II Apr-10-2020
5 Carestream Health, Inc. II Apr-23-2019
6 FUJIFILM Healthcare Americas Corporation II Sep-16-2022
7 GE Healthcare Japan Corporation II Aug-17-2018
8 GE Healthcare, LLC II Apr-05-2022
9 GE Healthcare, LLC II Nov-24-2021
10 GE Healthcare, LLC II Jul-08-2021
11 GE Healthcare, LLC II Jul-08-2021
12 GE Healthcare, LLC II Jun-25-2021
13 GE Healthcare, LLC II Feb-17-2021
14 GE Healthcare, LLC II Dec-22-2020
15 GE Healthcare, LLC II Oct-29-2020
16 GE Healthcare, LLC II Jul-12-2019
17 GE Healthcare, LLC II May-03-2019
18 GE Healthcare, LLC II Feb-06-2019
19 GE Healthcare, LLC II Jul-31-2018
20 GE Healthcare, LLC II Jun-12-2017
21 Hitachi Medical Systems America Inc II Nov-01-2019
22 Hitachi Medical Systems America Inc II Aug-17-2018
23 Imactis II Mar-16-2021
24 Imactis II Sep-15-2020
25 Imactis II Jan-22-2020
26 Mobius Imaging, LLC II Sep-14-2018
27 Mobius Imaging, LLC II Feb-24-2018
28 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
29 NeuroLogica Corporation II Aug-07-2020
30 Neusoft Medical Systems Co., Ltd. II May-21-2019
31 Neusoft Medical Systems Co., Ltd. II Aug-28-2017
32 Philips Electronics North America Corporation II Oct-13-2017
33 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
34 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
35 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
36 Philips Medical Systems (Cleveland) Inc II Nov-30-2018
37 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
38 Philips Medical Systems (Cleveland) Inc II Jul-02-2018
39 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
40 Philips Medical Systems (Cleveland) Inc II Jun-12-2018
41 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
42 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
43 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
44 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
45 Philips Medical Systems (Cleveland) Inc II Feb-09-2018
46 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
47 Philips Medical Systems (Cleveland) Inc II Jan-23-2018
48 Philips Medical Systems (Cleveland) Inc II Jan-19-2018
49 Philips Medical Systems (Cleveland) Inc II Jan-11-2018
50 Philips Medical Systems (Cleveland) Inc II Mar-20-2017
51 Philips Medical Systems (Cleveland) Inc II Jan-20-2017
52 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
53 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
54 Philips North America, LLC II May-06-2020
55 Philips North America Llc II Nov-24-2021
56 Philips North America Llc II Aug-18-2021
57 Philips North America Llc II Jun-30-2021
58 Philips North America Llc II Jun-02-2021
59 Philips North America Llc II Mar-16-2021
60 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
61 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
62 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
63 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
64 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
65 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
66 Siemens Medical Solutions USA, Inc II Aug-26-2022
67 Siemens Medical Solutions USA, Inc II Jul-06-2022
68 Siemens Medical Solutions USA, Inc II Apr-22-2022
69 Siemens Medical Solutions USA, Inc II Apr-20-2022
70 Siemens Medical Solutions USA, Inc II Jan-10-2022
71 Siemens Medical Solutions USA, Inc II Nov-24-2021
72 Siemens Medical Solutions USA, Inc II Sep-21-2021
73 Siemens Medical Solutions USA, Inc II Sep-10-2021
74 Siemens Medical Solutions USA, Inc II Mar-15-2021
75 Siemens Medical Solutions USA, Inc II Jan-09-2021
76 Siemens Medical Solutions USA, Inc II Sep-28-2020
77 Siemens Medical Solutions USA, Inc II Nov-21-2019
78 Siemens Medical Solutions USA, Inc II Nov-14-2019
79 Siemens Medical Solutions USA, Inc II Aug-30-2019
80 Siemens Medical Solutions USA, Inc II Aug-28-2019
81 Siemens Medical Solutions USA, Inc II Aug-14-2019
82 Siemens Medical Solutions USA, Inc II Jul-02-2019
83 Siemens Medical Solutions USA, Inc II Jul-02-2019
84 Siemens Medical Solutions USA, Inc II May-03-2019
85 Siemens Medical Solutions USA, Inc II Apr-09-2019
86 Siemens Medical Solutions USA, Inc II May-25-2018
87 Siemens Medical Solutions USA, Inc II May-15-2018
88 Siemens Medical Solutions USA, Inc II Apr-30-2018
89 Siemens Medical Solutions USA, Inc II Mar-30-2018
90 Siemens Medical Solutions USA, Inc II Feb-24-2018
91 Siemens Medical Solutions USA, Inc II Jun-21-2017
92 Siemens Medical Solutions USA, Inc. II Jun-08-2018
93 Siemens Medical Solutions USA, Inc. II May-02-2018
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