TPLC - Total Product Life Cycle

• Device: coil, magnetic resonance, specialty
• Regulation Description: Magnetic resonance diagnostic device.
• Product Code: MOS
• Regulation Number: 892.1000
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DXTX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
	SUBSTANTIALLY EQUIVALENT	2
INKSPACE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	5
INSIGHT MEDBOTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
	SUBSTANTIALLY EQUIVALENT	6
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	4
PHILIPS MEDICAL SYSTEM NEDERLANDS B.V.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	6
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	3
QFIX
	SUBSTANTIALLY EQUIVALENT	1
QUALITY ELECTRODYNAMICS
	SUBSTANTIALLY EQUIVALENT	3
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	7

MDR Year	MDR Reports	MDR Events
2019	8	8
2020	2	2
2021	3	3
2022	5	5
2023	4	4
2024	8	8
2025	2	2
2026	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Device Problem Information	13	13
Improper or Incorrect Procedure or Method	8	8
Adverse Event Without Identified Device or Use Problem	3	3
Electrical /Electronic Property Problem	2	2
Break	1	1
Use of Device Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
No Apparent Adverse Event	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Intermittent Continuity	1	1
Loose or Intermittent Connection	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	11	11
Superficial (First Degree) Burn	5	5
Burn, Thermal	3	3
No Known Impact Or Consequence To Patient	3	3
Burn(s)	3	3
Burning Sensation	3	3
No Clinical Signs, Symptoms or Conditions	2	2
Blister	2	2
Erythema	2	2
Laceration(s)	2	2
Bone Fracture(s)	1	1
Head Injury	1	1
Multiple Fractures	1	1
Itching Sensation	1	1
Rash	1	1
Insufficient Information	1	1
Unspecified Tissue Injury	1	1
No Consequences Or Impact To Patient	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	II	Oct-07-2019
2	Invivo Corporation	III	Oct-20-2020
3	Philips North America Llc	II	Nov-25-2024
4	Philips North America Llc	I	Jun-27-2024
5	Quality Electrodynamics LLC	II	Oct-03-2019