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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
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 23
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A.
  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 6
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 1
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
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 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 11
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND, 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 4
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
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 6
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 120 120
2018 156 156
2019 157 157
2020 98 98
2021 83 83
2022 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 231 231
Use of Device Problem 133 133
Improper or Incorrect Procedure or Method 95 95
Insufficient Information 78 78
Patient-Device Incompatibility 26 26
Electromagnetic Interference 20 20
Device Operates Differently Than Expected 19 19
Temperature Problem 19 19
Overheating of Device 18 18
Fire 14 14
Smoking 9 9
Arcing 9 9
Patient Device Interaction Problem 9 9
Unintended Movement 8 8
Device Handling Problem 8 8
Thermal Decomposition of Device 8 8
Device Emits Odor 7 7
Device Issue 7 7
Noise, Audible 7 7
No Apparent Adverse Event 7 7
Device Unsafe to Use in Environment 6 6
Device-Device Incompatibility 6 6
Break 6 6
Poor Quality Image 5 5
Mechanical Problem 5 5
Human Factors Issue 5 5
Detachment of Device or Device Component 5 5
Defective Device 4 4
Electromagnetic Compatibility Problem 4 4
Loose or Intermittent Connection 4 4
Unintended Collision 4 4
Electrical /Electronic Property Problem 4 4
Computer Software Problem 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4 4
Therapeutic or Diagnostic Output Failure 4 4
Appropriate Term/Code Not Available 4 4
Excessive Heating 4 4
Entrapment of Device 3 3
Display or Visual Feedback Problem 3 3
Melted 3 3
Unexpected Therapeutic Results 3 3
Human-Device Interface Problem 3 3
Output Problem 3 3
Device Displays Incorrect Message 3 3
Device Inoperable 3 3
Connection Problem 3 3
Communication or Transmission Problem 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
Image Orientation Incorrect 2 2
Device Slipped 2 2
Loss of Power 2 2
Unintended Magnet Quench 2 2
Nonstandard Device 2 2
Collapse 2 2
Device Fell 2 2
Missing Value Reason 2 2
Protective Measures Problem 2 2
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembled During Installation 1 1
Misassembly During Maintenance/Repair 1 1
Detachment Of Device Component 1 1
Air Leak 1 1
Signal Artifact/Noise 1 1
Disconnection 1 1
Crack 1 1
Fracture 1 1
Fail-Safe Design Failure 1 1
False Reading From Device Non-Compliance 1 1
Unintended System Motion 1 1
Device Abrasion From Instrument Or Another Object 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Inadequate or Insufficient Training 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Computer Operating System Problem 1 1
Failure to Align 1 1
Dent in Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Defective Component 1 1
Component Missing 1 1
Radiofrequency Interference (RFI) 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 102 102
Injury 89 89
Burn(s) 72 72
Bone Fracture(s) 59 59
Pain 53 54
Patient Problem/Medical Problem 51 51
Full thickness (Third Degree) Burn 47 47
No Known Impact Or Consequence To Patient 46 46
Burn, Thermal 46 47
Tinnitus 46 46
Laceration(s) 34 34
No Clinical Signs, Symptoms or Conditions 33 33
Burning Sensation 32 32
Erythema 27 28
Swelling 25 25
Hearing Loss 23 23
Radiation Burn 21 21
No Consequences Or Impact To Patient 21 21
Hearing Impairment 20 20
No Code Available 18 18
No Patient Involvement 16 16
Superficial (First Degree) Burn 16 16
Headache 14 14
Insufficient Information 14 14
Skin Irritation 13 13
Head Injury 8 8
Blister 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Bruise/Contusion 6 6
Tissue Damage 6 6
Nausea 6 6
Necrosis 6 6
Partial Hearing Loss 6 6
No Information 6 6
Dizziness 6 6
Discomfort 6 6
Skin Inflammation 6 6
Numbness 5 5
Alteration In Body Temperature 5 5
Itching Sensation 5 6
Abrasion 5 5
Death 5 5
Ambulation Difficulties 4 4
Confusion/ Disorientation 4 4
Complaint, Ill-Defined 4 4
Suture Abrasion 4 4
Misdiagnosis 4 4
Brain Injury 3 3
Electric Shock 3 3
Palpitations 3 3
Foreign Body In Patient 3 3
Multiple Fractures 3 3
Chest Pain 3 3
Crushing Injury 3 3
Eye Injury 3 3
Fall 3 3
Fatigue 3 3
Rash 3 3
Visual Disturbances 3 3
Vomiting 3 3
Unspecified Infection 3 3
Unspecified Tissue Injury 3 3
Alteration in Body Temperature 2 2
Limb Fracture 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Memory Loss/Impairment 2 2
Peeling 2 2
Skin Discoloration 2 2
Fever 2 2
Dry Eye(s) 2 2
Dyspnea 2 2
Emotional Changes 2 2
Hair Loss 2 2
Cardiac Arrest 2 2
Cataract 2 2
Lead(s), Burn(s) From 2 2
Pallor 2 2
Cognitive Changes 2 2
Reaction 2 2
Polydipsia 2 3
Excessive Tear Production 2 2
Ulcer 2 2
Twitching 2 2
Physical Entrapment 2 2
Urticaria 2 2
Fracture, Arm 2 2
Arthralgia 2 2
Malaise 2 2
Depression 2 2
Shaking/Tremors 2 2
Sweating 2 2
Vitreous Detachment 2 2
Neck Pain 2 2
Loss of consciousness 2 2
Irritability 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1
Neck Stiffness 1 1
Reaction, Injection Site 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 Healthcare, LLC II Feb-10-2017
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 GE Medical Systems, LLC II Aug-02-2017
20 Hitachi Healthcare Americas Corporation II Aug-24-2021
21 Hitachi Medical Systems America Inc II Jul-18-2018
22 Hitachi Medical Systems America Inc II Mar-23-2017
23 Hitachi Medical Systems America Inc II Jan-26-2017
24 Invivo Corporation II Mar-04-2020
25 NordicNeuroLab AS II Sep-11-2018
26 NordicNeuroLab AS II Jun-06-2018
27 Philips Electronics North America Corporation II Apr-18-2018
28 Philips Medical Systems Nederlands II Apr-27-2019
29 Philips Medical Systems Nederlands II Feb-22-2019
30 Philips Medical Systems Nederlands II Jan-08-2019
31 Philips North America Llc II Sep-03-2021
32 Philips North America Llc II Aug-25-2021
33 Philips North America Llc II Jun-04-2021
34 Siemens Medical Solutions USA, Inc II Sep-10-2021
35 Siemens Medical Solutions USA, Inc II Aug-22-2019
36 Siemens Medical Solutions USA, Inc II Apr-10-2017
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