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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coil, magnetic resonance, specialty
Product CodeMOS
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 4
INKSPACE IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
  SUBSTANTIALLY EQUIVALENT 1
LMT MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MORAS MRI PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MR INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 4
NORAS MRI PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 3
NOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 1
QUALITY ELECTRODYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 7
RAPID BIOMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RF TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 9 9
2018 7 7
2019 8 8
2020 2 2
2021 2 2
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Improper or Incorrect Procedure or Method 3 3
Patient-Device Incompatibility 2 2
Temperature Problem 2 2
Insufficient Information 2 2
Device Operates Differently Than Expected 2 2
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Device Fell 1 1
Excessive Heating 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Defective Device 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Partial thickness (Second Degree) Burn 5 5
Burn, Thermal 4 4
Burn(s) 4 4
Erythema 3 3
Full thickness (Third Degree) Burn 3 3
Bone Fracture(s) 2 2
Itching Sensation 2 2
Rash 2 2
Swelling 2 2
Burning Sensation 2 2
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Injury 1 1
Reaction 1 1
Sweating 1 1
Skin Discoloration 1 1
Nerve Damage 1 1
Pain 1 1
Head Injury 1 1
Headache 1 1
No Information 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Oct-07-2019
2 Invivo Corporation III Oct-20-2020
3 Quality Electrodynamics LLC II Oct-03-2019
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