TPLC - Total Product Life Cycle

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Device	coil, magnetic resonance, specialty
Product Code	MOS
Regulation Number	892.1000
Device Class	2

Premarket Reviews
Manufacturer	Decision
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
	SUBSTANTIALLY EQUIVALENT	1
INKSPACE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	3
INSIGHT MEDBOTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
	SUBSTANTIALLY EQUIVALENT	6
NEOCOIL, LLC
	SUBSTANTIALLY EQUIVALENT	3
NORAS MRI PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	2
NOVA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDICAL SYSTEM NEDERLANDS B.V.
	SUBSTANTIALLY EQUIVALENT	1
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	2
QFIX
	SUBSTANTIALLY EQUIVALENT	1
QUALITY ELECTRODYNAMICS
	SUBSTANTIALLY EQUIVALENT	2
QUALITY ELECTRODYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	3
RAPID BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN RF TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8	8
Improper or Incorrect Procedure or Method	3	3
Insufficient Information	2	2
Use of Device Problem	2	2
Excessive Heating	1	1
Temperature Problem	1	1
Structural Problem	1	1
Detachment of Device or Device Component	1	1
Device Unsafe to Use in Environment	1	1
Material Deformation	1	1
Break	1	1
Thermal Decomposition of Device	1	1
Intermittent Continuity	1	1
Loose or Intermittent Connection	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	5	5
Burn, Thermal	3	3
No Known Impact Or Consequence To Patient	3	3
No Clinical Signs, Symptoms or Conditions	2	2
Burn(s)	2	2
Erythema	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Burning Sensation	1	1
No Consequences Or Impact To Patient	1	1
Superficial (First Degree) Burn	1	1
Multiple Fractures	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