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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 11
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
GE HANGWEI MEDICAL SYSTEMS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
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
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 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 27
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
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 262 262
2022 77 78

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 277 277
Application Program Problem 105 105
Device Operates Differently Than Expected 72 72
Device Operational Issue 64 64
Use of Device Problem 50 50
Device Displays Incorrect Message 46 46
Patient Data Problem 46 46
Sharp Edges 45 45
Image Display Error/Artifact 40 40
Break 39 39
Insufficient Information 34 34
Material Fragmentation 32 32
Improper or Incorrect Procedure or Method 30 30
No Audible Alarm 29 29
Device Inoperable 27 27
Display or Visual Feedback Problem 25 25
Connection Problem 25 25
Application Network Problem 22 22
Mechanical Problem 22 22
Communication or Transmission Problem 21 21
Computer Software Problem 19 19
Defective Device 17 17
Unintended Movement 17 17
Application Program Freezes, Becomes Nonfunctional 17 17
No Display/Image 16 16
Unintended System Motion 14 14
Failure to Advance 13 13
Detachment of Device or Device Component 12 12
Poor Quality Image 11 11
Unexpected Shutdown 11 11
Human-Device Interface Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Defective Component 10 10
Device Sensing Problem 10 10
Programming Issue 9 9
Crack 9 9
Loss of Power 8 8
Material Separation 8 8
Unintended Electrical Shock 8 8
Device Handling Problem 7 7
Noise, Audible 7 7
Patient Device Interaction Problem 7 7
Failure to Power Up 7 7
Data Problem 7 7
Computer Operating System Problem 7 7
Appropriate Term/Code Not Available 6 6
Material Deformation 6 6
Radiofrequency Interference (RFI) 6 6
Detachment Of Device Component 6 6
Electrical /Electronic Property Problem 6 6
Fire 5 5
Radiation Overexposure 5 5
Positioning Problem 5 5
Power Problem 5 5
Output Problem 5 5
Protective Measures Problem 4 4
No Apparent Adverse Event 4 4
Material Integrity Problem 4 4
Installation-Related Problem 4 4
Improper Device Output 4 4
Inadequate User Interface 4 4
Device Markings/Labelling Problem 4 4
Activation, Positioning or SeparationProblem 4 4
Disconnection 4 4
Erratic or Intermittent Display 4 4
Loose or Intermittent Connection 4 4
Use of Incorrect Control Settings 4 4
Migration or Expulsion of Device 4 4
Unintended Collision 4 4
Inadequate or Insufficient Training 4 4
Unstable 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 Resultor Readings 3 3
Component Falling 3 3
Positioning Failure 3 3
Device Alarm System 3 3
Thermal Decomposition of Device 3 3
Physical Property Issue 3 3
Component Missing 3 3
Device Dislodged or Dislocated 3 3
Battery Problem 3 3
Calibration Problem 3 3
Component or Accessory Incompatibility 2 2
Electrical Shorting 2 2
Device Issue 2 2
Failure to Calibrate 2 2
Incorrect Or Inadequate Test Results 2 2
Arcing 2 2
Operating System Becomes Nonfunctional 2 2
Gas Leak 2 2
Human Factors Issue 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 581 581
Pneumothorax 141 141
No Clinical Signs, Symptoms or Conditions 138 138
No Code Available 115 115
No Consequences Or Impact To Patient 89 89
Death 70 70
Radiation Exposure, Unintended 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 64 64
No Information 62 62
Laceration(s) 57 57
Insufficient Information 46 46
Blood Loss 35 35
Injury 34 34
Bone Fracture(s) 22 22
No Patient Involvement 14 14
Unintended Radiation Exposure 14 14
Abrasion 13 13
Hemorrhage/Bleeding 12 12
Cardiac Arrest 11 11
Bruise/Contusion 9 9
Head Injury 9 9
Patient Problem/Medical Problem 8 8
Electric Shock 7 7
Respiratory Failure 7 7
Chest Pain 7 7
Pain 6 6
Misdiagnosis 6 6
Limb Fracture 6 6
Headache 5 5
Radiation Overdose 4 4
Nausea 4 4
Physical Entrapment 4 4
Fracture, Arm 4 4
Suture Abrasion 3 3
Skin Tears 3 3
Cough 3 3
Not Applicable 3 3
Unspecified Tissue Injury 3 3
Hypoxia 3 3
Swelling 3 3
Tachycardia 3 3
Brain Injury 3 3
Vomiting 3 3
Burn(s) 3 3
Burning Sensation 3 3
Fever 3 3
Crushing Injury 3 3
Fall 3 3
Fatigue 2 2
Hearing Impairment 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Bradycardia 2 2
Airway Obstruction 2 2
Dizziness 2 2
Unspecified Infection 2 2
Hemorrhagic Stroke 2 2
Missing Value Reason 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Numbness 2 2
Chemical Exposure 2 2
Low Oxygen Saturation 2 2
Superficial (First Degree) Burn 2 2
Foreign Body In Patient 2 2
Loss of consciousness 2 2
Hip Fracture 2 2
Discomfort 1 1
Arthralgia 1 1
Malaise 1 1
Impaired Healing 1 1
Tooth Fracture 1 1
Sweating 1 1
Vitreous Detachment 1 1
Diaphoresis 1 1
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Alteration In Body Temperature 1 1
Full thickness (Third Degree) Burn 1 1
Weight Changes 1 1
Coma 1 1
Cancer 1 1
Syncope/Fainting 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Unspecified Reproductive System or Breast Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Muscle/Tendon Damage 1 1
Skin Burning Sensation 1 1
Unspecified Nervous System Problem 1 1
Irritation 1 1
Muscle Weakness 1 1
Oversedation 1 1
Paralysis 1 1
Pneumonia 1 1
Tinnitus 1 1
Tissue Damage 1 1
Urinary Retention 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 GE Healthcare Japan Corporation II Aug-17-2018
7 GE Healthcare, LLC II Apr-05-2022
8 GE Healthcare, LLC II Nov-24-2021
9 GE Healthcare, LLC II Jul-08-2021
10 GE Healthcare, LLC II Jul-08-2021
11 GE Healthcare, LLC II Jun-25-2021
12 GE Healthcare, LLC II Feb-17-2021
13 GE Healthcare, LLC II Dec-22-2020
14 GE Healthcare, LLC II Oct-29-2020
15 GE Healthcare, LLC II Jul-12-2019
16 GE Healthcare, LLC II May-03-2019
17 GE Healthcare, LLC II Feb-06-2019
18 GE Healthcare, LLC II Jul-31-2018
19 GE Healthcare, LLC II Jun-12-2017
20 Hitachi Medical Systems America Inc II Nov-01-2019
21 Hitachi Medical Systems America Inc II Aug-17-2018
22 Imactis II Mar-16-2021
23 Imactis II Sep-15-2020
24 Imactis II Jan-22-2020
25 Mobius Imaging, LLC II Sep-14-2018
26 Mobius Imaging, LLC II Feb-24-2018
27 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
28 NeuroLogica Corporation II Aug-07-2020
29 Neusoft Medical Systems Co., Ltd. II May-21-2019
30 Neusoft Medical Systems Co., Ltd. II Aug-28-2017
31 Philips Electronics North America Corporation II Oct-13-2017
32 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
33 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
34 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
35 Philips Medical Systems (Cleveland) Inc II Nov-30-2018
36 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
37 Philips Medical Systems (Cleveland) Inc II Jul-02-2018
38 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
39 Philips Medical Systems (Cleveland) Inc II Jun-12-2018
40 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
41 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
42 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
43 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
44 Philips Medical Systems (Cleveland) Inc II Feb-09-2018
45 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
46 Philips Medical Systems (Cleveland) Inc II Jan-23-2018
47 Philips Medical Systems (Cleveland) Inc II Jan-19-2018
48 Philips Medical Systems (Cleveland) Inc II Jan-11-2018
49 Philips Medical Systems (Cleveland) Inc II Mar-20-2017
50 Philips Medical Systems (Cleveland) Inc II Jan-20-2017
51 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
52 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
53 Philips North America, LLC II May-06-2020
54 Philips North America Llc II Nov-24-2021
55 Philips North America Llc II Aug-18-2021
56 Philips North America Llc II Jun-30-2021
57 Philips North America Llc II Jun-02-2021
58 Philips North America Llc II Mar-16-2021
59 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
60 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
61 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
62 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
63 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
64 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
65 Siemens Medical Solutions USA, Inc II Apr-22-2022
66 Siemens Medical Solutions USA, Inc II Apr-20-2022
67 Siemens Medical Solutions USA, Inc II Jan-10-2022
68 Siemens Medical Solutions USA, Inc II Nov-24-2021
69 Siemens Medical Solutions USA, Inc II Sep-21-2021
70 Siemens Medical Solutions USA, Inc II Sep-10-2021
71 Siemens Medical Solutions USA, Inc II Mar-15-2021
72 Siemens Medical Solutions USA, Inc II Jan-09-2021
73 Siemens Medical Solutions USA, Inc II Sep-28-2020
74 Siemens Medical Solutions USA, Inc II Nov-21-2019
75 Siemens Medical Solutions USA, Inc II Nov-14-2019
76 Siemens Medical Solutions USA, Inc II Aug-30-2019
77 Siemens Medical Solutions USA, Inc II Aug-28-2019
78 Siemens Medical Solutions USA, Inc II Aug-14-2019
79 Siemens Medical Solutions USA, Inc II Jul-02-2019
80 Siemens Medical Solutions USA, Inc II Jul-02-2019
81 Siemens Medical Solutions USA, Inc II May-03-2019
82 Siemens Medical Solutions USA, Inc II Apr-09-2019
83 Siemens Medical Solutions USA, Inc II May-25-2018
84 Siemens Medical Solutions USA, Inc II May-15-2018
85 Siemens Medical Solutions USA, Inc II Apr-30-2018
86 Siemens Medical Solutions USA, Inc II Mar-30-2018
87 Siemens Medical Solutions USA, Inc II Feb-24-2018
88 Siemens Medical Solutions USA, Inc II Jun-21-2017
89 Siemens Medical Solutions USA, Inc. II Jun-08-2018
90 Siemens Medical Solutions USA, Inc. II May-02-2018
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