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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
AMRA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ASG SUPERCONDUCTORS S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
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 1
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
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 3
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 2
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 1
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 11
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
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 28
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 5
SYNTHETICMR AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 1
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 233 233
Use of Device Problem 154 154
Improper or Incorrect Procedure or Method 122 122
Insufficient Information 120 120
Patient-Device Incompatibility 28 28
Patient Device Interaction Problem 19 19
Temperature Problem 18 18
Electromagnetic Interference 16 16
Overheating of Device 13 13
Device Handling Problem 13 13
No Apparent Adverse Event 12 12
Fire 12 12
Detachment of Device or Device Component 11 11
Excessive Heating 10 10
Unintended Movement 8 8
Device-Device Incompatibility 8 8
Smoking 7 7
Device Emits Odor 7 7
Noise, Audible 7 7
Appropriate Term/Code Not Available 7 7
Misassembled During Installation 7 7
Break 6 6
Thermal Decomposition of Device 6 6
Device Unsafe to Use in Environment 6 6
Arcing 6 6
Defective Device 6 6
Connection Problem 5 5
Poor Quality Image 5 5
Unexpected Therapeutic Results 5 5
Output Problem 5 5
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Computer Software Problem 4 4
Electrical /Electronic Property Problem 4 4
Device Operates Differently Than Expected 4 4
Device Issue 4 4
Malposition of Device 3 3
Electromagnetic Compatibility Problem 3 3
Human-Device Interface Problem 3 3
Entrapment of Device 3 3
Display or Visual Feedback Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Mechanical Problem 3 3
Melted 3 3
Unintended Collision 3 3
Positioning Problem 3 3
Installation-Related Problem 3 3
Mechanical Jam 3 3
Unintended Electrical Shock 3 3
Device Fell 2 2
Human Factors Issue 2 2
Nonstandard Device 2 2
Loss of Power 2 2
Collapse 2 2
Image Orientation Incorrect 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Environmental Compatibility Problem 2 2
Electrical Overstress 2 2
Loose or Intermittent Connection 2 2
Device Damaged by Another Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 1 1
Volume Accuracy Problem 1 1
Defective Component 1 1
Component Missing 1 1
Radiofrequency Interference (RFI) 1 1
Failure to Align 1 1
Dent in Material 1 1
Failure to Fire 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Healthcare Professional 1 1
Fracture 1 1
Signal Artifact/Noise 1 1
Detachment Of Device Component 1 1
Degraded 1 1
No Display/Image 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Physical Property Issue 1 1
Missing Value Reason 1 1
Unexpected Shutdown 1 1
Radiation Output Problem 1 1
Migration 1 1
Explosion 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 102 102
No Clinical Signs, Symptoms or Conditions 81 81
Burn(s) 76 76
Bone Fracture(s) 70 70
Injury 63 63
Pain 61 61
Tinnitus 54 54
Full thickness (Third Degree) Burn 51 51
Patient Problem/Medical Problem 45 45
Laceration(s) 38 38
Burning Sensation 36 36
Burn, Thermal 35 36
No Known Impact Or Consequence To Patient 34 34
Superficial (First Degree) Burn 34 34
Hearing Impairment 29 29
Erythema 25 25
Blister 21 21
Insufficient Information 20 20
Swelling 19 19
Radiation Burn 18 18
Hearing Loss 17 17
Headache 14 14
No Consequences Or Impact To Patient 13 13
Skin Irritation 12 12
No Code Available 12 12
Unspecified Tissue Injury 11 11
No Patient Involvement 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Partial Hearing Loss 9 9
Head Injury 8 8
Nausea 7 7
Discomfort 7 7
Multiple Fractures 7 7
Skin Burning Sensation 7 7
Skin Inflammation 6 6
Electric Shock 5 5
Sleep Dysfunction 5 5
Numbness 5 5
Dizziness 5 5
Necrosis 5 5
Bruise/Contusion 5 5
Abrasion 5 5
Cardiac Arrest 4 4
Death 4 4
Tissue Damage 4 4
Rash 4 4
Confusion/ Disorientation 4 4
Alteration In Body Temperature 4 4
Ambulation Difficulties 4 4
Suture Abrasion 3 3
Cognitive Changes 3 3
Foreign Body In Patient 3 3
No Information 3 3
Ulcer 3 3
Vomiting 3 3
Misdiagnosis 3 3
Tingling 3 3
Neck Pain 3 3
Brain Injury 3 3
Itching Sensation 3 3
Skin Discoloration 3 3
Peeling 3 3
Chest Pain 3 3
Crushing Injury 3 3
Eye Injury 3 3
Fall 3 3
Emotional Changes 3 3
Limb Fracture 3 3
Unspecified Ear or Labyrinth Problem 3 3
Unspecified Heart Problem 3 3
Convulsion/Seizure 2 2
Total Hearing Loss 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Implant Pain 2 2
Alteration in Body Temperature 2 2
Swelling/ Edema 2 2
Diarrhea 2 2
Dyspnea 2 2
Fatigue 2 2
Fever 2 2
Cataract 2 2
Blurred Vision 2 2
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Unspecified Infection 2 2
Fracture, Arm 2 2
Malaise 2 2
Depression 2 2
Joint Dislocation 2 2
Reaction 2 2
Tooth Fracture 2 2
Loss of consciousness 2 2
Twitching 2 2
Concussion 2 2
Visual Disturbances 2 2
Lead(s), Burn(s) From 2 2
Fluid Discharge 2 2
Palpitations 2 2
Sweating 2 2
Vitreous Detachment 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, Inc. II Dec-31-2019
5 Deerfield Imaging, Inc. II May-04-2018
6 GE Healthcare, LLC II Jul-21-2022
7 GE Healthcare, LLC II Apr-21-2022
8 GE Healthcare, LLC II Apr-04-2022
9 GE Healthcare, LLC II Feb-09-2022
10 GE Healthcare, LLC II Oct-16-2021
11 GE Healthcare, LLC II Jul-12-2021
12 GE Healthcare, LLC II Oct-20-2020
13 GE Healthcare, LLC II Jan-28-2020
14 GE Healthcare, LLC II Jan-07-2019
15 GE Medical Systems, LLC II Oct-24-2018
16 GE Medical Systems, LLC II Oct-15-2018
17 GE Medical Systems, LLC II Sep-27-2018
18 GE Medical Systems, LLC II Jul-23-2018
19 Hitachi Healthcare Americas Corporation II Aug-24-2021
20 Hitachi Medical Systems America Inc II Jul-18-2018
21 Invivo Corporation II Mar-04-2020
22 NordicNeuroLab AS II Sep-11-2018
23 NordicNeuroLab AS II Jun-06-2018
24 Philips Electronics North America Corporation II Apr-18-2018
25 Philips Medical Systems Nederlands II Apr-27-2019
26 Philips Medical Systems Nederlands II Feb-22-2019
27 Philips Medical Systems Nederlands II Jan-08-2019
28 Philips North America II Feb-02-2024
29 Philips North America III Jan-25-2024
30 Philips North America II Aug-11-2023
31 Philips North America II Aug-11-2023
32 Philips North America Llc II Apr-17-2024
33 Philips North America Llc I Dec-14-2023
34 Philips North America Llc II Nov-21-2023
35 Philips North America Llc II Dec-08-2022
36 Philips North America Llc II Sep-03-2021
37 Philips North America Llc II Aug-25-2021
38 Philips North America Llc II Jun-04-2021
39 Siemens Medical Solutions USA, Inc II Sep-29-2023
40 Siemens Medical Solutions USA, Inc II Sep-10-2021
41 Siemens Medical Solutions USA, Inc II Aug-22-2019
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