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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
ARINETA LTD.
  SUBSTANTIALLY EQUIVALENT 1
BUNKERHILL, INC
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 15
CANON MEDICAL SYSTEMS USA
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 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 4
IMACTIS, SAS
  SUBSTANTIALLY EQUIVALENT 1
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ISYS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
MOBIUS IMAGING, LLC
  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
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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
PHILLIPS MEDICAL SYSTEMS (CLEVELAND) 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 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 27
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THIRONA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  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 2

MDR Year MDR Reports MDR Events
2018 542 542
2019 233 233
2020 177 177
2021 261 261
2022 200 201
2023 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Signal Artifact/Noise 279 279
Degraded 225 225
Adverse Event Without Identified Device or Use Problem 201 201
Application Program Problem 132 132
Device Operational Issue 61 61
Use of Device Problem 59 59
Device Displays Incorrect Message 53 53
Patient Data Problem 50 50
Sharp Edges 45 45
Insufficient Information 44 44
Image Display Error/Artifact 41 41
Device Operates Differently Than Expected 39 39
Break 38 38
Material Fragmentation 36 36
Improper or Incorrect Procedure or Method 35 35
Computer Software Problem 32 32
Display or Visual Feedback Problem 30 30
Connection Problem 30 30
Communication or Transmission Problem 23 23
Defective Device 22 22
No Audible Alarm 21 21
Device Inoperable 21 21
Mechanical Problem 21 21
Application Program Freezes, Becomes Nonfunctional 19 19
No Display/Image 17 17
Application Network Problem 16 16
Unintended Movement 16 16
Unexpected Shutdown 15 15
Unintended System Motion 15 15
Detachment of Device or Device Component 14 14
Output Problem 14 14
Failure to Advance 12 12
Electrical /Electronic Property Problem 12 12
Defective Component 11 11
Device Sensing Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Poor Quality Image 10 10
Material Separation 10 10
Retraction Problem 10 10
Device Handling Problem 10 10
Unintended Electrical Shock 8 8
Crack 8 8
Failure to Power Up 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 7 7
Appropriate Term/Code Not Available 7 7
Data Problem 7 7
Radiation Overexposure 6 6
Device Dislodged or Dislocated 6 6
Radiofrequency Interference (RFI) 6 6
Computer Operating System Problem 5 5
Power Problem 5 5
Loss of Power 5 5
Unintended Collision 5 5
Fire 5 5
Erratic or Intermittent Display 5 5
Disconnection 4 4
Loose or Intermittent Connection 4 4
Positioning Failure 4 4
Use of Incorrect Control/Treatment Settings 4 4
Migration or Expulsion of Device 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Inadequate or Insufficient Training 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Material Integrity Problem 4 4
Material Twisted/Bent 4 4
Human-Device Interface Problem 4 4
Activation, Positioning or Separation Problem 4 4
Calibration Problem 4 4
Noise, Audible 4 4
Unintended Application Program Shut Down 4 4
Program or Algorithm Execution Problem 4 4
Device Fell 3 3
Battery Problem 3 3
Arcing 3 3
Device Markings/Labelling Problem 3 3
Loss of Data 3 3
Component Missing 3 3
Improper Device Output 3 3
Installation-Related Problem 3 3
Operating System Becomes Nonfunctional 3 3
Device Stops Intermittently 3 3
Unstable 3 3
Smoking 3 3
Detachment Of Device Component 3 3
Component Falling 3 3
Device Alarm System 3 3
Entrapment of Device 3 3
Fluid/Blood Leak 2 2
Application Program Problem: Dose Calculation Error 2 2
Image Orientation Incorrect 2 2
Imprecision 2 2
Circuit Failure 2 2
Unintended Power Up 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Premature Activation 2 2
Product Quality Problem 2 2
No Device Output 2 2
Misconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 429 429
No Clinical Signs, Symptoms or Conditions 217 217
Pneumothorax 125 125
No Code Available 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 92 92
No Consequences Or Impact To Patient 73 73
Insufficient Information 64 64
Radiation Exposure, Unintended 57 57
No Information 55 55
Laceration(s) 55 55
Unintended Radiation Exposure 24 24
Blood Loss 21 21
Injury 21 21
Bone Fracture(s) 21 21
Hemorrhage/Bleeding 19 19
Death 17 17
Abrasion 17 17
Cardiac Arrest 12 12
No Patient Involvement 11 11
Bruise/Contusion 10 10
Electric Shock 9 9
Patient Problem/Medical Problem 8 8
Limb Fracture 7 7
Chest Pain 7 7
Head Injury 7 7
Misdiagnosis 6 6
Headache 5 5
Foreign Body In Patient 5 5
Respiratory Failure 5 5
Skin Tears 5 5
Unspecified Tissue Injury 4 4
Fall 4 4
Crushing Injury 4 4
Nausea 4 4
Hypersensitivity/Allergic reaction 3 3
Tachycardia 3 3
Vomiting 3 3
Radiation Overdose 3 3
Fever 3 3
Cough 3 3
Burning Sensation 3 3
Not Applicable 3 3
Cancer 2 2
Superficial (First Degree) Burn 2 2
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Suture Abrasion 2 2
Brain Injury 2 2
Physical Entrapment 2 2
Loss of consciousness 2 2
Respiratory Arrest 2 2
Hemorrhagic Stroke 2 2
Stroke/CVA 2 2
Fatigue 2 2
Airway Obstruction 2 2
Bradycardia 2 2
Burn(s) 2 2
Muscle Weakness 2 2
Dizziness 2 2
Hip Fracture 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Oversedation 2 2
Pain 2 2
Paralysis 1 1
Pneumonia 1 1
Unspecified Infection 1 1
Irritation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Loss of Range of Motion 1 1
Respiratory Distress 1 1
Sepsis 1 1
Shock 1 1
Swelling 1 1
Fracture, Arm 1 1
Arthralgia 1 1
Malaise 1 1
Impaired Healing 1 1
Numbness 1 1
Coma 1 1
Electrolyte Imbalance 1 1
Rupture 1 1
Weakness 1 1
Cardiopulmonary Arrest 1 1
Cyst(s) 1 1
Contusion 1 1
Apnea 1 1
Radiation Burn 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Dyspnea 1 1
Emotional Changes 1 1
Eye Injury 1 1
Hematoma 1 1
Hemoptysis 1 1
Intracranial Hemorrhage 1 1
Hair Loss 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 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 Jan-17-2023
26 Mobius Imaging, LLC II Dec-06-2022
27 Mobius Imaging, LLC II Sep-14-2018
28 Mobius Imaging, LLC II Feb-24-2018
29 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
30 NeuroLogica Corporation II Aug-07-2020
31 Neusoft Medical Systems Co., Ltd. II May-21-2019
32 Olympus Corporation of the Americas II Feb-07-2023
33 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
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 Medical Systems (Cleveland) Inc II Nov-30-2018
38 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
39 Philips Medical Systems (Cleveland) Inc II Jul-02-2018
40 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
41 Philips Medical Systems (Cleveland) Inc II Jun-12-2018
42 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
43 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
44 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
45 Philips Medical Systems (Cleveland) Inc II Mar-02-2018
46 Philips Medical Systems (Cleveland) Inc II Feb-09-2018
47 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
48 Philips Medical Systems (Cleveland) Inc II Jan-23-2018
49 Philips Medical Systems (Cleveland) Inc II Jan-19-2018
50 Philips Medical Systems (Cleveland) Inc II Jan-11-2018
51 Philips North America, LLC II May-06-2020
52 Philips North America II May-12-2023
53 Philips North America Llc II May-12-2023
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 Jan-20-2023
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-08-2018
92 Siemens Medical Solutions USA, Inc. II May-02-2018
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