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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
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 230 230
Use of Device Problem 131 131
Improper or Incorrect Procedure or Method 95 95
Insufficient Information 76 76
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 13 13
Smoking 9 9
Arcing 9 9
Thermal Decomposition of Device 8 8
Unintended Movement 8 8
Device Handling Problem 8 8
Patient Device Interaction Problem 8 8
No Apparent Adverse Event 7 7
Device Emits Odor 7 7
Device Issue 7 7
Device Unsafe to Use in Environment 6 6
Device-Device Incompatibility 6 6
Break 6 6
Noise, Audible 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
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 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
Device Displays Incorrect Message 3 3
Device Inoperable 3 3
Connection Problem 3 3
Communication or Transmission Problem 2 2
Environmental Compatibility Problem 2 2
Device Damaged by Another Device 2 2
Output Problem 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Image Orientation Incorrect 2 2
Device Slipped 2 2
Loss of Power 2 2
Unintended Magnet Quench 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
Device Abrasion From Instrument Or Another Object 1 1
Unintended System Motion 1 1
Nonstandard Device 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
Material Deformation 1 1
Material Integrity Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 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) 56 56
Pain 52 53
Patient Problem/Medical Problem 51 51
Tinnitus 46 46
Burn, Thermal 46 47
Full thickness (Third Degree) Burn 46 46
No Known Impact Or Consequence To Patient 46 46
Laceration(s) 33 33
Burning Sensation 32 32
No Clinical Signs, Symptoms or Conditions 31 31
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
Superficial (First Degree) Burn 16 16
No Patient Involvement 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
Partial Hearing Loss 6 6
Skin Inflammation 6 6
No Information 6 6
Tissue Damage 6 6
Bruise/Contusion 6 6
Nausea 6 6
Necrosis 6 6
Dizziness 6 6
Discomfort 6 6
Itching Sensation 5 6
Alteration In Body Temperature 5 5
Numbness 5 5
Death 5 5
Abrasion 5 5
Misdiagnosis 4 4
Confusion/ Disorientation 4 4
Ambulation Difficulties 4 4
Complaint, Ill-Defined 4 4
Suture Abrasion 4 4
Vomiting 3 3
Eye Injury 3 3
Chest Pain 3 3
Unspecified Infection 3 3
Multiple Fractures 3 3
Palpitations 3 3
Visual Disturbances 3 3
Rash 3 3
Fatigue 3 3
Crushing Injury 3 3
Electric Shock 3 3
Unspecified Tissue Injury 3 3
Foreign Body In Patient 3 3
Brain Injury 3 3
Fall 3 3
Pallor 2 2
Physical Entrapment 2 2
Malaise 2 2
Loss of consciousness 2 2
Dry Eye(s) 2 2
Dyspnea 2 2
Cataract 2 2
Hypersensitivity/Allergic reaction 2 2
Lead(s), Burn(s) From 2 2
Arthralgia 2 2
Hemorrhage/Bleeding 2 2
Polydipsia 2 3
Twitching 2 2
Fever 2 2
Skin Discoloration 2 2
Memory Loss/Impairment 2 2
Peeling 2 2
Fracture, Arm 2 2
Excessive Tear Production 2 2
Ulcer 2 2
Neck Pain 2 2
Cognitive Changes 2 2
Sweating 2 2
Limb Fracture 2 2
Hair Loss 2 2
Cardiac Arrest 2 2
Urticaria 2 2
Depression 2 2
Reaction 2 2
Shaking/Tremors 2 2
Vitreous Detachment 2 2
Blood Loss 1 1
Tooth Fracture 1 1
Weakness 1 1
Diarrhea 1 1
Extreme Exhaustion 1 1
Radiation Overdose 1 1
Acoustic Trauma 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 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 GE Healthcare, LLC II Feb-10-2017
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 GE Medical Systems, LLC II Aug-02-2017
19 Hitachi Healthcare Americas Corporation II Aug-24-2021
20 Hitachi Medical Systems America Inc II Jul-18-2018
21 Hitachi Medical Systems America Inc II Mar-23-2017
22 Hitachi Medical Systems America Inc II Jan-26-2017
23 Invivo Corporation II Mar-04-2020
24 NordicNeuroLab AS II Sep-11-2018
25 NordicNeuroLab AS II Jun-06-2018
26 Philips Electronics North America Corporation II Apr-18-2018
27 Philips Medical Systems Nederlands II Apr-27-2019
28 Philips Medical Systems Nederlands II Feb-22-2019
29 Philips Medical Systems Nederlands II Jan-08-2019
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
35 Siemens Medical Solutions USA, Inc II Apr-10-2017
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