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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nuclear magnetic resonance imaging
Product CodeLNH
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLTECH MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMRA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ASG SUPERCONDUCTORS S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
ASPECT IMAGING LTD
  SUBSTANTIALLY EQUIVALENT 1
ASPECT IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 27
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 9
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 2
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 4
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
INNOVERE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KINETICOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGEMETRIC LLC
  SUBSTANTIALLY EQUIVALENT 1
MRI DIVISION, BEIJING WANDONG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MRI DIVISION,BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MRIAUDIO
  SUBSTANTIALLY EQUIVALENT 1
MRIAUDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOCARDIAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEURO42, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 2
NORTHH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
NOUS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM DIAGNOSTICS LTD
  SUBSTANTIALLY EQUIVALENT 2
PERSPECTUM LTD
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 14
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 1
PROMAXO, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
RESOUNDANT INC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RF TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 35
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI)
  SUBSTANTIALLY EQUIVALENT 1
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 6
SYNTHETICMR AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 1
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 134 134
2017 120 120
2018 156 156
2019 157 157
2020 98 98
2021 83 83
2022 138 138
2023 159 159
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 295 295
Insufficient Information 185 185
Use of Device Problem 171 171
Improper or Incorrect Procedure or Method 150 150
Patient-Device Incompatibility 31 31
Device Operates Differently Than Expected 28 28
Overheating of Device 24 24
Electromagnetic Interference 22 22
Temperature Problem 22 22
Patient Device Interaction Problem 19 19
Fire 16 16
Thermal Decomposition of Device 15 15
Device Emits Odor 14 14
Device Handling Problem 14 14
Noise, Audible 14 14
No Apparent Adverse Event 14 14
Human Factors Issue 12 12
Detachment of Device or Device Component 11 11
Unintended Movement 11 11
Smoking 11 11
Device Issue 11 11
Arcing 10 10
Appropriate Term/Code Not Available 10 10
Excessive Heating 10 10
Radiofrequency Interference (RFI) 9 9
Break 9 9
Device-Device Incompatibility 8 8
Connection Problem 7 7
Misassembled During Installation 7 7
Electrical /Electronic Property Problem 7 7
Mechanical Problem 7 7
Defective Device 6 6
Device Unsafe to Use in Environment 6 6
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 5 5
Unexpected Therapeutic Results 5 5
Poor Quality Image 5 5
Unintended Collision 5 5
Loose or Intermittent Connection 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Computer Software Problem 5 5
Detachment Of Device Component 4 4
Entrapment of Device 4 4
Device Displays Incorrect Message 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Inadequate User Interface 4 4
Electromagnetic Compatibility Problem 4 4
Communication or Transmission Problem 3 3
Installation-Related Problem 3 3
Human-Device Interface Problem 3 3
Mechanical Jam 3 3
Unintended Electrical Shock 3 3
Malposition of Device 3 3
Device Slipped 3 3
Device Inoperable 3 3
Display or Visual Feedback Problem 3 3
Device Stops Intermittently 3 3
Loss of Power 3 3
Image Orientation Incorrect 3 3
Melted 3 3
Unintended Magnet Quench 2 2
Fracture 2 2
Circuit Failure 2 2
Collapse 2 2
Signal Artifact/Noise 2 2
Inadequacy of Device Shape and/or Size 2 2
Nonstandard Device 2 2
Device Fell 2 2
Missing Value Reason 2 2
Material Integrity Problem 2 2
Physical Property Issue 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Compatibility Problem 2 2
Device Damaged by Another Device 2 2
Environmental Compatibility Problem 2 2
Electrical Overstress 2 2
Electrical Shorting 2 2
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Device Operational Issue 1 1
Computer Operating System Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Improper Device Output 1 1
Radiation Overexposure 1 1
Migration 1 1
Explosion 1 1
Misassembly During Maintenance/Repair 1 1
Key or Button Unresponsive/not Working 1 1
Unexpected Shutdown 1 1
Radiation Output Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Normal 1 1
Inadequate or Insufficient Training 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 131 132
Burn(s) 117 117
Injury 98 98
Bone Fracture(s) 85 85
No Clinical Signs, Symptoms or Conditions 81 81
Pain 78 81
Full thickness (Third Degree) Burn 72 72
Tinnitus 63 63
No Known Impact Or Consequence To Patient 55 55
Patient Problem/Medical Problem 54 54
Laceration(s) 53 53
Burn, Thermal 51 52
Burning Sensation 47 49
Erythema 39 41
Superficial (First Degree) Burn 39 40
Hearing Loss 34 34
No Consequences Or Impact To Patient 34 34
Hearing Impairment 33 33
Swelling 27 27
Radiation Burn 25 25
No Patient Involvement 24 24
No Code Available 21 21
Blister 21 21
Insufficient Information 20 20
Headache 17 17
Skin Irritation 13 13
Discomfort 12 12
Death 11 11
Unspecified Tissue Injury 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Partial Hearing Loss 9 9
No Information 9 9
Nausea 9 9
Dizziness 9 9
Tissue Damage 8 8
Head Injury 8 8
Bruise/Contusion 7 7
Necrosis 7 7
Itching Sensation 7 8
Skin Inflammation 7 7
Confusion/ Disorientation 7 7
Multiple Fractures 7 7
Skin Burning Sensation 7 7
Alteration In Body Temperature 6 6
Ambulation Difficulties 6 6
Sleep Dysfunction 6 6
Suture Abrasion 6 6
Rash 6 6
Abrasion 6 6
Emotional Changes 5 5
Eye Injury 5 5
Dyspnea 5 5
Skin Discoloration 5 5
Electric Shock 5 5
Numbness 5 5
Complaint, Ill-Defined 4 4
Sweating 4 4
Joint Dislocation 4 4
Neck Pain 4 4
Vomiting 4 4
Misdiagnosis 4 4
Tingling 4 4
Physical Entrapment 4 4
Hemorrhage/Bleeding 4 4
Hypersensitivity/Allergic reaction 4 4
Unspecified Infection 4 4
Memory Loss/Impairment 4 4
Fall 4 4
Cardiac Arrest 4 4
Chest Pain 4 4
Foreign Body In Patient 4 4
Unspecified Ear or Labyrinth Problem 3 3
Unspecified Heart Problem 3 3
Limb Fracture 3 3
Crushing Injury 3 3
Fatigue 3 3
Muscle Weakness 3 3
Peeling 3 3
Visual Disturbances 3 3
Brain Injury 3 3
Ulcer 3 3
Concussion 3 3
Blurred Vision 3 3
Palpitations 3 3
Cognitive Changes 3 3
Reaction 3 3
Depression 3 3
Excessive Tear Production 2 2
Loss of consciousness 2 2
Tooth Fracture 2 2
Vitreous Detachment 2 2
Pallor 2 2
Shaking/Tremors 2 2
Visual Impairment 2 2
Cramp(s) 2 2
Twitching 2 2
Weakness 2 2
Rupture 2 2
Urticaria 2 2
Fracture, Arm 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Mar-04-2024
2 Canon Medical System, USA, INC. II Jul-09-2021
3 Canon Medical System, USA, INC. II Oct-22-2018
4 Deerfield Imaging II Mar-11-2016
5 Deerfield Imaging, Inc. II Dec-31-2019
6 Deerfield Imaging, Inc. II May-04-2018
7 Esaote S.p.A. II Jul-05-2016
8 GE Healthcare, LLC II Jul-21-2022
9 GE Healthcare, LLC II Apr-21-2022
10 GE Healthcare, LLC II Apr-04-2022
11 GE Healthcare, LLC II Feb-09-2022
12 GE Healthcare, LLC II Oct-16-2021
13 GE Healthcare, LLC II Jul-12-2021
14 GE Healthcare, LLC II Oct-20-2020
15 GE Healthcare, LLC II Jan-28-2020
16 GE Healthcare, LLC II Jan-07-2019
17 GE Healthcare, LLC II Feb-10-2017
18 GE Healthcare, LLC II Sep-02-2016
19 GE Healthcare, LLC II Jul-06-2016
20 GE Healthcare, LLC II Jun-08-2016
21 GE Medical Systems, LLC II Oct-24-2018
22 GE Medical Systems, LLC II Oct-15-2018
23 GE Medical Systems, LLC II Sep-27-2018
24 GE Medical Systems, LLC II Jul-23-2018
25 GE Medical Systems, LLC II Aug-02-2017
26 GE Medical Systems, LLC II Apr-07-2016
27 Hitachi Healthcare Americas Corporation II Aug-24-2021
28 Hitachi Medical Systems America Inc II Jul-18-2018
29 Hitachi Medical Systems America Inc II Mar-23-2017
30 Hitachi Medical Systems America Inc II Jan-26-2017
31 Invivo Corporation II Mar-04-2020
32 MWT Materials, Inc. II Jan-21-2016
33 Medtronic Navigation II Jul-06-2016
34 NordicNeuroLab AS II Sep-11-2018
35 NordicNeuroLab AS II Jun-06-2018
36 Philips Electronics North America Corporation II Apr-18-2018
37 Philips Electronics North America Corporation II Dec-19-2016
38 Philips Electronics North America Corporation II Feb-26-2016
39 Philips Medical Systems Nederlands II Apr-27-2019
40 Philips Medical Systems Nederlands II Feb-22-2019
41 Philips Medical Systems Nederlands II Jan-08-2019
42 Philips North America II Feb-02-2024
43 Philips North America III Jan-25-2024
44 Philips North America II Aug-11-2023
45 Philips North America II Aug-11-2023
46 Philips North America Llc II Apr-17-2024
47 Philips North America Llc I Dec-14-2023
48 Philips North America Llc II Nov-21-2023
49 Philips North America Llc II Dec-08-2022
50 Philips North America Llc II Sep-03-2021
51 Philips North America Llc II Aug-25-2021
52 Philips North America Llc II Jun-04-2021
53 Siemens Medical Solutions USA, Inc II Sep-29-2023
54 Siemens Medical Solutions USA, Inc II Sep-10-2021
55 Siemens Medical Solutions USA, Inc II Aug-22-2019
56 Siemens Medical Solutions USA, Inc II Apr-10-2017
57 Siemens Medical Solutions USA, Inc II May-03-2016
58 Toshiba American Medical Systems Inc II Jul-06-2016
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