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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 1
ASG SUPERCONDUCTORS S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 25
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
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
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
INNOVERE MEDICAL 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, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOCARDIAL SOLUTIONS
  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 MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 6
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 7
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 5
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 22
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 2
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 3
SYNTHETICMR AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 1
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 175 175
Use of Device Problem 138 138
Improper or Incorrect Procedure or Method 110 110
Insufficient Information 93 93
Patient-Device Incompatibility 21 21
Patient Device Interaction Problem 18 18
Temperature Problem 16 16
Electromagnetic Interference 14 14
Device Handling Problem 13 13
No Apparent Adverse Event 12 12
Excessive Heating 10 10
Overheating of Device 10 10
Fire 9 9
Detachment of Device or Device Component 9 9
Device-Device Incompatibility 8 8
Misassembled During Installation 7 7
Noise, Audible 6 6
Unintended Movement 6 6
Break 6 6
Arcing 6 6
Defective Device 6 6
Smoking 6 6
Device Emits Odor 5 5
Thermal Decomposition of Device 5 5
Poor Quality Image 5 5
Connection Problem 5 5
Output Problem 5 5
Device Unsafe to Use in Environment 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Appropriate Term/Code Not Available 4 4
Electrical /Electronic Property Problem 4 4
Unexpected Therapeutic Results 4 4
Unintended Collision 3 3
Malposition of Device 3 3
Mechanical Problem 3 3
Melted 3 3
Unintended Electrical Shock 3 3
Mechanical Jam 3 3
Positioning Problem 3 3
Human-Device Interface Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 2 2
Loose or Intermittent Connection 2 2
Electrical Overstress 2 2
Electromagnetic Compatibility Problem 2 2
Nonstandard Device 2 2
Collapse 2 2
Computer Software Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 1 1
Energy Output Problem 1 1
Inadequate or Insufficient Training 1 1
Volume Accuracy Problem 1 1
Contamination /Decontamination Problem 1 1
Computer Operating System Problem 1 1
Defective Component 1 1
Radiofrequency Interference (RFI) 1 1
Failure to Align 1 1
Degraded 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Image Orientation Incorrect 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loss of Power 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
Environmental Compatibility Problem 1 1
Electrical Shorting 1 1
Device Damaged by Another Device 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Unexpected Shutdown 1 1
Radiation Output Problem 1 1
Migration 1 1
Explosion 1 1
Misassembly During Maintenance/Repair 1 1
Key or Button Unresponsive/not Working 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
Partial thickness (Second Degree) Burn 80 80
Burn(s) 63 63
Bone Fracture(s) 54 54
Tinnitus 51 51
Pain 46 46
Full thickness (Third Degree) Burn 40 40
Patient Problem/Medical Problem 35 35
Injury 35 35
Superficial (First Degree) Burn 33 33
Laceration(s) 32 32
Burning Sensation 30 30
Hearing Impairment 28 28
Burn, Thermal 27 28
No Known Impact Or Consequence To Patient 21 21
Blister 21 21
Insufficient Information 20 20
Erythema 18 18
Hearing Loss 11 11
Unspecified Tissue Injury 11 11
Headache 10 10
Swelling 10 10
Radiation Burn 9 9
Partial Hearing Loss 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Skin Burning Sensation 7 7
Multiple Fractures 7 7
Discomfort 7 7
Skin Irritation 7 7
No Patient Involvement 6 6
Electric Shock 5 5
Sleep Dysfunction 5 5
No Code Available 5 5
No Consequences Or Impact To Patient 5 5
Skin Inflammation 5 5
Nausea 5 5
Tissue Damage 4 4
Head Injury 4 4
Bruise/Contusion 4 4
Abrasion 4 4
Cardiac Arrest 4 4
Ambulation Difficulties 4 4
Unspecified Heart Problem 3 3
Numbness 3 3
Brain Injury 3 3
Misdiagnosis 3 3
Tingling 3 3
Dizziness 3 3
Ulcer 3 3
Emotional Changes 3 3
Rash 3 3
Skin Discoloration 3 3
Peeling 3 3
Unspecified Ear or Labyrinth Problem 3 3
Limb Fracture 3 3
Unspecified Mental, Emotional or Behavioural Problem 2 2
Implant Pain 2 2
Alteration in Body Temperature 2 2
Swelling/ Edema 2 2
Necrosis 2 2
Unspecified Infection 2 2
Muscle Weakness 2 2
Itching Sensation 2 2
Vomiting 2 2
Blurred Vision 2 2
Dyspnea 2 2
Eye Injury 2 2
Fall 2 2
Fatigue 2 2
Cataract 2 2
Chest Pain 2 2
Crushing Injury 2 2
Death 2 2
Twitching 2 2
Concussion 2 2
Loss of consciousness 2 2
Malaise 2 2
Depression 2 2
Joint Dislocation 2 2
Tooth Fracture 2 2
Neck Pain 2 2
Palpitations 2 2
Total Hearing Loss 2 2
Convulsion/Seizure 2 2
Lead(s), Burn(s) From 2 2
No Information 2 2
Confusion/ Disorientation 2 2
Vitreous Detachment 2 2
Fluid Discharge 2 2
Foreign Body In Patient 2 2
Alteration In Body Temperature 1 1
Heart rate, increased 1 1
Blood Loss 1 1
Abdominal Distention 1 1
Weight Changes 1 1
Diaphoresis 1 1
Chest Tightness/Pressure 1 1
Abdominal Cramps 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1

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 Deerfield Imaging, Inc. II Dec-31-2019
4 GE Healthcare, LLC II Jul-21-2022
5 GE Healthcare, LLC II Apr-21-2022
6 GE Healthcare, LLC II Apr-04-2022
7 GE Healthcare, LLC II Feb-09-2022
8 GE Healthcare, LLC II Oct-16-2021
9 GE Healthcare, LLC II Jul-12-2021
10 GE Healthcare, LLC II Oct-20-2020
11 GE Healthcare, LLC II Jan-28-2020
12 GE Healthcare, LLC II Jan-07-2019
13 Hitachi Healthcare Americas Corporation II Aug-24-2021
14 Invivo Corporation II Mar-04-2020
15 Philips Medical Systems Nederlands II Apr-27-2019
16 Philips Medical Systems Nederlands II Feb-22-2019
17 Philips Medical Systems Nederlands II Jan-08-2019
18 Philips North America II Feb-02-2024
19 Philips North America III Jan-25-2024
20 Philips North America II Aug-11-2023
21 Philips North America II Aug-11-2023
22 Philips North America Llc II Apr-17-2024
23 Philips North America Llc I Dec-14-2023
24 Philips North America Llc II Nov-21-2023
25 Philips North America Llc II Dec-08-2022
26 Philips North America Llc II Sep-03-2021
27 Philips North America Llc II Aug-25-2021
28 Philips North America Llc II Jun-04-2021
29 Siemens Medical Solutions USA, Inc II Sep-29-2023
30 Siemens Medical Solutions USA, Inc II Sep-10-2021
31 Siemens Medical Solutions USA, Inc II Aug-22-2019
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