TPLC - Total Product Life Cycle

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Device	image-intensified fluoroscopic x-ray system, mobile
Definition	Fluoroscopy of the human body.
Product Code	OXO
Regulation Number	892.1650
Device Class	2

Premarket Reviews
Manufacturer	Decision
GE HUALUN MEDICAL SYSTEMS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE OEC MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	2
TURNER IMAGING SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEHM-ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	1507	1507
Positioning Problem	307	307
Communication or Transmission Problem	269	269
Unexpected Shutdown	255	255
Failure to Run on Battery	201	201
Failure to Power Up	190	190
Noise, Audible	180	180
Imprecision	154	154
Adverse Event Without Identified Device or Use Problem	150	150
Poor Quality Image	149	149
Failure to Charge	146	146
Material Deformation	105	105
Physical Resistance/Sticking	75	75
Use of Device Problem	69	69
Smoking	66	66
Device Sensing Problem	64	64
Radiation Output Failure	62	62
Image Display Error/Artifact	58	58
Incorrect, Inadequate or Imprecise Result or Readings	44	44
Application Program Problem	37	37
Power Problem	33	33
Unintended Movement	31	31
No Display/Image	29	29
Arcing	29	29
Failure to Advance	27	27
Calibration Problem	26	26
Wireless Communication Problem	22	22
Radiation Output Problem	21	21
Unintended Electrical Shock	17	17
Mechanical Problem	15	15
Data Problem	14	14
Connection Problem	11	11
Electrical /Electronic Property Problem	9	9
Overheating of Device	7	7
Unexpected/Unintended Radiation Output	6	6
Operating System Becomes Nonfunctional	5	5
Output Problem	5	5
Temperature Problem	5	5
Computer Operating System Problem	4	4
Component Missing	4	4
Problem with Software Installation	4	4
Device Fell	4	4
Failure to Align	3	3
Computer Software Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Transmit Record	3	3
Unintended System Motion	3	3
Display or Visual Feedback Problem	3	3
Device Displays Incorrect Message	3	3
Failure to Shut Off	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	1466	1466
No Clinical Signs, Symptoms or Conditions	1354	1354
No Known Impact Or Consequence To Patient	532	532
Unspecified Tissue Injury	70	70
Unspecified Infection	23	23
Pain	21	21
Unspecified Nervous System Problem	20	20
Insufficient Information	19	19
Post Operative Wound Infection	18	18
Hemorrhage/Bleeding	18	18
Tissue Damage	13	13
Muscle Weakness	13	13
Hematoma	12	12
Cerebrospinal Fluid Leakage	12	12
Numbness	9	9
Nerve Damage	8	8
Cognitive Changes	6	6
Dysphasia	5	5
Dysphagia/ Odynophagia	5	5
Loss of Range of Motion	5	5
Radiation Exposure, Unintended	5	5
Urinary Retention	5	5
Thrombosis/Thrombus	5	5
Bacterial Infection	5	5
Swelling/ Edema	4	4
Intracranial Hemorrhage	4	4
No Consequences Or Impact To Patient	4	4
Spinal Column Injury	4	4
Tissue Breakdown	4	4
Erosion	3	3
Paralysis	3	3
Pulmonary Emphysema	3	3
Bone Fracture(s)	3	3
Nervous System Injury	3	3
Neuropathy	3	3
Cardiac Arrest	2	2
Dyskinesia	2	2
Confusion/ Disorientation	2	2
Injury	2	2
Convulsion/Seizure	2	2
Perforation	2	2
Thrombosis	2	2
Necrosis	2	2
Depression	2	2
Ambulation Difficulties	2	2
Impaired Healing	2	2
Dyspnea	2	2
Paraplegia	1	1
Skin Tears	1	1
Cardiovascular Insufficiency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE OEC Medical Systems, Inc	II	Dec-18-2024
2	GE OEC Medical Systems, Inc	II	Jul-31-2023
3	GE OEC Medical Systems, Inc	II	Jul-29-2021
4	Medtronic Navigation, Inc.-Littleton	II	Jul-03-2019