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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 26
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
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 6
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
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 1
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 6
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 20
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 1
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 5
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 105 105

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 223 223
Use of Device Problem 141 141
Improper or Incorrect Procedure or Method 108 108
Insufficient Information 86 86
Patient-Device Incompatibility 28 28
Patient Device Interaction Problem 19 19
Temperature Problem 18 18
Electromagnetic Interference 16 16
Overheating of Device 13 13
Fire 12 12
No Apparent Adverse Event 12 12
Detachment of Device or Device Component 11 11
Device Handling Problem 10 10
Unintended Movement 8 8
Device-Device Incompatibility 8 8
Smoking 7 7
Device Emits Odor 7 7
Noise, Audible 7 7
Excessive Heating 7 7
Misassembled During Installation 6 6
Device Unsafe to Use in Environment 6 6
Break 6 6
Thermal Decomposition of Device 6 6
Arcing 6 6
Defective Device 6 6
Poor Quality Image 5 5
Unexpected Therapeutic Results 5 5
Output Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Protective Measures Problem 4 4
Appropriate Term/Code Not Available 4 4
Computer Software Problem 4 4
Device Issue 4 4
Device Operates Differently Than Expected 4 4
Electromagnetic Compatibility Problem 3 3
Human-Device Interface Problem 3 3
Malposition of Device 3 3
Connection Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Electrical /Electronic Property Problem 3 3
Entrapment of Device 3 3
Display or Visual Feedback Problem 3 3
Mechanical Problem 3 3
Melted 3 3
Unintended Collision 3 3
Unintended Electrical Shock 3 3
Device Fell 2 2
Positioning Problem 2 2
Human Factors Issue 2 2
Nonstandard Device 2 2
Loss of Power 2 2
Image Orientation Incorrect 2 2
Collapse 2 2
Inadequacy of Device Shape and/or Size 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Environmental Compatibility Problem 2 2
Device Damaged by Another Device 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Electrical Overstress 1 1
Electrical Shorting 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Device Slipped 1 1
Failure to Align 1 1
Dent in Material 1 1
Defective Component 1 1
Component Missing 1 1
Radiofrequency Interference (RFI) 1 1
Failure to Fire 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Detachment Of Device Component 1 1
Degraded 1 1
No Display/Image 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Fracture 1 1
Signal Artifact/Noise 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
Physical Property Issue 1 1
Missing Value Reason 1 1
Migration 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 95 95
Burn(s) 71 71
Bone Fracture(s) 63 63
Injury 63 63
No Clinical Signs, Symptoms or Conditions 62 62
Pain 59 59
Tinnitus 48 48
Full thickness (Third Degree) Burn 47 47
Patient Problem/Medical Problem 45 45
Burn, Thermal 35 36
No Known Impact Or Consequence To Patient 34 34
Burning Sensation 34 34
Laceration(s) 33 33
Superficial (First Degree) Burn 29 29
Hearing Impairment 25 25
Erythema 23 23
Swelling 19 19
Insufficient Information 18 18
Blister 17 17
Hearing Loss 17 17
Radiation Burn 16 16
Headache 13 13
No Consequences Or Impact To Patient 13 13
No Code Available 12 12
Skin Irritation 12 12
No Patient Involvement 11 11
Unspecified Tissue Injury 10 10
Partial Hearing Loss 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Head Injury 8 8
Nausea 7 7
Discomfort 7 7
Multiple Fractures 7 7
Skin Inflammation 6 6
Numbness 5 5
Dizziness 5 5
Electric Shock 5 5
Necrosis 5 5
Abrasion 5 5
Bruise/Contusion 5 5
Cardiac Arrest 4 4
Death 4 4
Tissue Damage 4 4
Ambulation Difficulties 4 4
Alteration In Body Temperature 4 4
Confusion/ Disorientation 3 3
Sleep Dysfunction 3 3
Suture Abrasion 3 3
Misdiagnosis 3 3
Tingling 3 3
Brain Injury 3 3
Ulcer 3 3
Neck Pain 3 3
Vomiting 3 3
Skin Discoloration 3 3
Emotional Changes 3 3
Eye Injury 3 3
Fall 3 3
Chest Pain 3 3
Crushing Injury 3 3
No Information 3 3
Limb Fracture 3 3
Total Hearing Loss 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Unspecified Heart Problem 2 2
Implant Pain 2 2
Alteration in Body Temperature 2 2
Skin Burning Sensation 2 2
Swelling/ Edema 2 2
Cataract 2 2
Diarrhea 2 2
Fatigue 2 2
Fever 2 2
Itching Sensation 2 2
Rash 2 2
Blurred Vision 2 2
Peeling 2 2
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Joint Dislocation 2 2
Sweating 2 2
Vitreous Detachment 2 2
Loss of consciousness 2 2
Fracture, Arm 2 2
Malaise 2 2
Twitching 2 2
Concussion 2 2
Visual Disturbances 2 2
Palpitations 2 2
Reaction 2 2
Cognitive Changes 2 2
Foreign Body In Patient 2 2
Lead(s), Burn(s) From 2 2
Radiation Exposure, Unintended 1 1
Lymphoma 1 1
Balance Problems 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Taste Disorder 1 1
Bowel Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Jul-09-2021
2 Canon Medical System, USA, INC. II Oct-22-2018
3 Deerfield Imaging, Inc. II Dec-31-2019
4 Deerfield Imaging, Inc. II May-04-2018
5 GE Healthcare, LLC II Jul-21-2022
6 GE Healthcare, LLC II Apr-21-2022
7 GE Healthcare, LLC II Apr-04-2022
8 GE Healthcare, LLC II Feb-09-2022
9 GE Healthcare, LLC II Oct-16-2021
10 GE Healthcare, LLC II Jul-12-2021
11 GE Healthcare, LLC II Oct-20-2020
12 GE Healthcare, LLC II Jan-28-2020
13 GE Healthcare, LLC II Jan-07-2019
14 GE Medical Systems, LLC II Oct-24-2018
15 GE Medical Systems, LLC II Oct-15-2018
16 GE Medical Systems, LLC II Sep-27-2018
17 GE Medical Systems, LLC II Jul-23-2018
18 Hitachi Healthcare Americas Corporation II Aug-24-2021
19 Hitachi Medical Systems America Inc II Jul-18-2018
20 Invivo Corporation II Mar-04-2020
21 NordicNeuroLab AS II Sep-11-2018
22 NordicNeuroLab AS II Jun-06-2018
23 Philips Electronics North America Corporation II Apr-18-2018
24 Philips Medical Systems Nederlands II Apr-27-2019
25 Philips Medical Systems Nederlands II Feb-22-2019
26 Philips Medical Systems Nederlands II Jan-08-2019
27 Philips North America II Aug-11-2023
28 Philips North America II Aug-11-2023
29 Philips North America Llc II Dec-08-2022
30 Philips North America Llc II Sep-03-2021
31 Philips North America Llc II Aug-25-2021
32 Philips North America Llc II Jun-04-2021
33 Siemens Medical Solutions USA, Inc II Sep-10-2021
34 Siemens Medical Solutions USA, Inc II Aug-22-2019
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