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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
Regulation Description Magnetic resonance diagnostic device.
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 1
ASG SUPERCONDUCTORS S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
ASPECT IMAGING LTD
  SUBSTANTIALLY EQUIVALENT 1
ASPECT IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 19
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 9
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
MRIAUDIO
  SUBSTANTIALLY EQUIVALENT 1
MRIAUDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOCARDIAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NORDICNEUROLAB AS
  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 10
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  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 4
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 19
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 5
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 134 134
2017 120 120
2018 156 156
2019 157 157
2020 98 98
2021 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 228 228
Use of Device Problem 124 124
Insufficient Information 96 96
Improper or Incorrect Procedure or Method 89 89
Device Operates Differently Than Expected 28 28
Patient-Device Incompatibility 25 25
Overheating of Device 23 23
Electromagnetic Interference 19 19
Temperature Problem 17 17
Thermal Decomposition of Device 14 14
Fire 13 13
Human Factors Issue 12 12
Noise, Audible 11 11
Device Issue 11 11
Device Emits Odor 10 10
Radiofrequency Interference (RFI) 9 9
Unintended Movement 9 9
Smoking 8 8
No Apparent Adverse Event 8 8
Appropriate Term/Code Not Available 7 7
Break 7 7
Arcing 7 7
Electrical /Electronic Property Problem 6 6
Mechanical Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Computer Software Problem 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Device Unsafe to Use in Environment 5 5
Device-Device Incompatibility 5 5
Connection Problem 4 4
Device Displays Incorrect Message 4 4
Detachment Of Device Component 4 4
Loose or Intermittent Connection 4 4
Excessive Heating 4 4
Patient Device Interaction Problem 4 4
Inadequate User Interface 3 3
Human-Device Interface Problem 3 3
Display or Visual Feedback Problem 3 3
Loss of Power 3 3
Communication or Transmission Problem 3 3
Detachment of Device or Device Component 3 3
Device Inoperable 3 3
Image Orientation Incorrect 3 3
Unintended Collision 3 3
Entrapment of Device 3 3
Poor Quality Image 3 3
Device Stops Intermittently 3 3
Electromagnetic Compatibility Problem 3 3
Unexpected Therapeutic Results 2 2
Circuit Failure 2 2
Material Integrity Problem 2 2
Compatibility Problem 2 2
Device Fell 2 2
Device Slipped 2 2
Unintended Magnet Quench 2 2
Signal Artifact/Noise 2 2
Fracture 2 2
Environmental Compatibility Problem 2 2
Device Damaged by Another Device 2 2
Installation-Related Problem 2 2
Physical Property Issue 2 2
Defective Device 2 2
Missing Value Reason 2 2
Device Handling Problem 1 1
Unintended Electrical Shock 1 1
Misassembled During Installation 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Device Operational Issue 1 1
Gas Leak 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Labelling, Instructions for Use or Training Problem 1 1
Image Reversal 1 1
Air Leak 1 1
Collapse 1 1
Crack 1 1
False Reading From Device Non-Compliance 1 1
Melted 1 1
Device Abrasion From Instrument Or Another Object 1 1
Nonstandard Device 1 1
Component Missing 1 1
Failure to Align 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Inadequate or Insufficient Training 1 1
No Device Output 1 1
Positioning Problem 1 1
Radiation Overexposure 1 1
Material Deformation 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembly During Maintenance/Repair 1 1
Fail-Safe Design Failure 1 1
Material Discolored 1 1
Disconnection 1 1
Unintended System Motion 1 1
Material Rupture 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Misassembled 1 1
Misconnection 1 1
Normal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 99 100
Injury 98 98
Burn(s) 94 94
Bone Fracture(s) 60 60
Pain 55 58
No Known Impact Or Consequence To Patient 55 55
Patient Problem/Medical Problem 54 54
Full thickness (Third Degree) Burn 52 52
Burn, Thermal 51 52
Tinnitus 37 37
Laceration(s) 36 36
Hearing Loss 34 34
No Consequences Or Impact To Patient 34 34
Erythema 32 34
Burning Sensation 29 31
Swelling 27 27
No Patient Involvement 24 24
Radiation Burn 22 22
Hearing Impairment 21 21
No Code Available 21 21
Superficial (First Degree) Burn 14 15
Skin Irritation 13 13
Headache 11 11
Death 11 11
Discomfort 9 9
No Information 9 9
Dizziness 8 8
Tissue Damage 8 8
Head Injury 7 7
Necrosis 7 7
Skin Inflammation 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Itching Sensation 6 7
Nausea 6 6
Bruise/Contusion 6 6
Alteration In Body Temperature 6 6
Suture Abrasion 6 6
Confusion/ Disorientation 5 5
Abrasion 5 5
Dyspnea 4 4
Memory Loss/Impairment 4 4
Rash 4 4
Sweating 4 4
Ambulation Difficulties 4 4
Skin Discoloration 4 4
Misdiagnosis 4 4
Physical Entrapment 4 4
Numbness 4 4
Insufficient Information 4 4
Complaint, Ill-Defined 4 4
Hemorrhage/Bleeding 4 4
Eye Injury 4 4
Unspecified Infection 3 3
Vomiting 3 3
Reaction 3 3
Foreign Body In Patient 3 3
Multiple Fractures 3 3
Blister 3 3
Unspecified Tissue Injury 3 3
Partial Hearing Loss 3 3
Palpitations 3 3
Visual Disturbances 3 3
Hypersensitivity/Allergic reaction 3 3
Fall 3 3
Fatigue 2 2
Fever 2 2
Emotional Changes 2 2
Crushing Injury 2 2
Intracranial Hemorrhage 2 2
Muscle Weakness 2 2
Sleep Dysfunction 2 2
Neck Pain 2 2
Cognitive Changes 2 2
Loss of consciousness 2 2
Fracture, Arm 2 2
Malaise 2 2
Joint Dislocation 2 2
Excessive Tear Production 2 2
Concussion 2 2
Cramp(s) 2 2
Lead(s), Burn(s) From 2 2
Polydipsia 2 3
Shaking/Tremors 2 2
Radiation Exposure, Unintended 2 2
Electric Shock 2 2
Weakness 2 2
Tingling 2 2
Twitching 2 2
Urticaria 2 2
Arthralgia 2 2
Depression 2 2
Blurred Vision 2 2
Visual Impairment 2 2
Peripheral Vascular Disease 2 2
Cardiac Arrest 2 2
Chest Pain 2 2
Abdominal Pain 2 2
Acoustic Trauma 1 1
Breast Cancer 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 II Mar-11-2016
4 Deerfield Imaging, Inc. II Dec-31-2019
5 Deerfield Imaging, Inc. II May-04-2018
6 Esaote S.p.A. II Jul-05-2016
7 GE Healthcare, LLC II Oct-16-2021
8 GE Healthcare, LLC II Jul-12-2021
9 GE Healthcare, LLC II Oct-20-2020
10 GE Healthcare, LLC II Jan-28-2020
11 GE Healthcare, LLC II Jan-07-2019
12 GE Healthcare, LLC II Feb-10-2017
13 GE Healthcare, LLC II Sep-02-2016
14 GE Healthcare, LLC II Jul-06-2016
15 GE Healthcare, LLC II Jun-08-2016
16 GE Medical Systems, LLC II Oct-24-2018
17 GE Medical Systems, LLC II Oct-15-2018
18 GE Medical Systems, LLC II Sep-27-2018
19 GE Medical Systems, LLC II Jul-23-2018
20 GE Medical Systems, LLC II Aug-02-2017
21 GE Medical Systems, LLC II Apr-07-2016
22 Hitachi Healthcare Americas Corporation II Aug-24-2021
23 Hitachi Medical Systems America Inc II Jul-18-2018
24 Hitachi Medical Systems America Inc II Mar-23-2017
25 Hitachi Medical Systems America Inc II Jan-26-2017
26 Invivo Corporation II Mar-04-2020
27 MWT Materials, Inc. II Jan-21-2016
28 Medtronic Navigation II Jul-06-2016
29 NordicNeuroLab AS II Sep-11-2018
30 NordicNeuroLab AS II Jun-06-2018
31 Philips Electronics North America Corporation II Apr-18-2018
32 Philips Electronics North America Corporation II Dec-19-2016
33 Philips Electronics North America Corporation II Feb-26-2016
34 Philips Medical Systems Nederlands II Apr-27-2019
35 Philips Medical Systems Nederlands II Feb-22-2019
36 Philips Medical Systems Nederlands II Jan-08-2019
37 Philips North America Llc II Sep-03-2021
38 Philips North America Llc II Aug-25-2021
39 Philips North America Llc II Jun-04-2021
40 Siemens Medical Solutions USA, Inc II Sep-10-2021
41 Siemens Medical Solutions USA, Inc II Aug-22-2019
42 Siemens Medical Solutions USA, Inc II Apr-10-2017
43 Siemens Medical Solutions USA, Inc II May-03-2016
44 Toshiba American Medical Systems Inc II Jul-06-2016
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