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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 25
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 1
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 1
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 5
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 9
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
PROMAXO, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RESOUNDANT INC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 18
SIEMENS MEDICAL SOLUTIONS, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 5
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 209 209
Use of Device Problem 127 127
Improper or Incorrect Procedure or Method 93 93
Insufficient Information 56 56
Patient-Device Incompatibility 27 27
Temperature Problem 16 16
Electromagnetic Interference 15 15
Overheating of Device 13 13
Patient Device Interaction Problem 12 12
Fire 11 11
Device Handling Problem 8 8
Device Emits Odor 7 7
Unintended Movement 7 7
Device-Device Incompatibility 7 7
Device Unsafe to Use in Environment 6 6
Arcing 6 6
No Apparent Adverse Event 6 6
Smoking 6 6
Thermal Decomposition of Device 6 6
Noise, Audible 6 6
Excessive Heating 5 5
Break 5 5
Poor Quality Image 5 5
Unexpected Therapeutic Results 5 5
Output Problem 5 5
Detachment of Device or Device Component 5 5
Device Operates Differently Than Expected 4 4
Defective Device 4 4
Device Issue 4 4
Therapeutic or Diagnostic Output Failure 4 4
Computer Software Problem 4 4
Appropriate Term/Code Not Available 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Display or Visual Feedback Problem 3 3
Electrical /Electronic Property Problem 3 3
Entrapment of Device 3 3
Mechanical Problem 3 3
Melted 3 3
Unintended Collision 3 3
Protective Measures Problem 3 3
Electromagnetic Compatibility Problem 3 3
Human-Device Interface Problem 3 3
Connection Problem 3 3
Device Damaged by Another Device 2 2
Environmental Compatibility Problem 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Human Factors Issue 2 2
Loss of Power 2 2
Nonstandard Device 2 2
Image Orientation Incorrect 2 2
Collapse 2 2
Device Fell 2 2
Unintended Electrical Shock 2 2
Unexpected Shutdown 1 1
Radiation Output Problem 1 1
Missing Value Reason 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembled During Installation 1 1
Misassembly During Maintenance/Repair 1 1
Key or Button Unresponsive/not Working 1 1
Detachment Of Device Component 1 1
Signal Artifact/Noise 1 1
Loose or Intermittent Connection 1 1
Fracture 1 1
Material Puncture/Hole 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Slipped 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Defective Component 1 1
Component Missing 1 1
Radiofrequency Interference (RFI) 1 1
Physical Property Issue 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Electrical Overstress 1 1
Electrical Shorting 1 1
Failure to Align 1 1
Dent in Material 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Failure to Fire 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 86 86
Burn(s) 67 67
Injury 63 63
Bone Fracture(s) 57 57
Pain 48 48
Patient Problem/Medical Problem 45 45
Tinnitus 43 43
Full thickness (Third Degree) Burn 42 42
No Clinical Signs, Symptoms or Conditions 39 39
Burn, Thermal 35 36
No Known Impact Or Consequence To Patient 34 34
Burning Sensation 30 30
Laceration(s) 30 30
Hearing Impairment 21 21
Erythema 21 21
Swelling 19 19
Superficial (First Degree) Burn 18 18
Hearing Loss 17 17
Radiation Burn 16 16
Insufficient Information 15 15
No Consequences Or Impact To Patient 13 13
No Code Available 12 12
Blister 12 12
Skin Irritation 12 12
Headache 12 12
No Patient Involvement 11 11
Partial Hearing Loss 8 8
Head Injury 8 8
Discomfort 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Skin Inflammation 6 6
Numbness 5 5
Electric Shock 5 5
Abrasion 5 5
Bruise/Contusion 5 5
Nausea 5 5
Necrosis 5 5
Multiple Fractures 5 5
Unspecified Tissue Injury 4 4
Tissue Damage 4 4
Death 4 4
Ambulation Difficulties 4 4
Alteration In Body Temperature 4 4
Dizziness 4 4
Brain Injury 3 3
Ulcer 3 3
Suture Abrasion 3 3
No Information 3 3
Chest Pain 3 3
Crushing Injury 3 3
Fall 3 3
Misdiagnosis 3 3
Visual Disturbances 2 2
Vomiting 2 2
Rash 2 2
Peeling 2 2
Itching Sensation 2 2
Memory Loss/Impairment 2 2
Fatigue 2 2
Fever 2 2
Emotional Changes 2 2
Eye Injury 2 2
Cataract 2 2
Cardiac Arrest 2 2
Limb Fracture 2 2
Lead(s), Burn(s) From 2 2
Foreign Body In Patient 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Reaction 2 2
Sleep Dysfunction 2 2
Palpitations 2 2
Sweating 2 2
Vitreous Detachment 2 2
Loss of consciousness 2 2
Joint Dislocation 2 2
Fracture, Arm 2 2
Malaise 2 2
Skin Discoloration 2 2
Twitching 2 2
Alteration in Body Temperature 2 2
Swelling/ Edema 2 2
Decreased Appetite 1 1
Muscle/Tendon Damage 1 1
Concussion 1 1
Cramp(s) 1 1
Excessive Tear Production 1 1
Rupture 1 1
Depression 1 1
Urinary Frequency 1 1
Pressure Sores 1 1
Physical Entrapment 1 1
Meningitis 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Irritability 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Neck Stiffness 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 Llc II Dec-08-2022
28 Philips North America Llc II Sep-03-2021
29 Philips North America Llc II Aug-25-2021
30 Philips North America Llc II Jun-04-2021
31 Siemens Medical Solutions USA, Inc II Sep-10-2021
32 Siemens Medical Solutions USA, Inc II Aug-22-2019
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