TPLC - Total Product Life Cycle

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Device	image-intensified fluoroscopic x-ray system, mobile
Regulation Description	Image-intensified fluoroscopic x-ray system.
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
HEFEI CHIMED INTELLIGENT MACHINE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	2
TURNER IMAGING SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEHM-ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	1540	1540
Positioning Problem	309	309
Communication or Transmission Problem	273	273
Unexpected Shutdown	255	255
Failure to Run on Battery	202	202
Failure to Power Up	190	190
Noise, Audible	184	184
Adverse Event Without Identified Device or Use Problem	173	173
Imprecision	154	154
Poor Quality Image	150	150
Failure to Charge	148	148
Material Deformation	106	106
Radiation Output Failure	85	85
Physical Resistance/Sticking	75	75
Use of Device Problem	71	71
Smoking	70	70
Device Sensing Problem	65	65
Image Display Error/Artifact	57	57
Incorrect, Inadequate or Imprecise Result or Readings	52	52
Failure to Advance	45	45
Application Program Problem	40	40
Power Problem	33	33
Unintended Movement	31	31
Arcing	29	29
No Display/Image	29	29
Calibration Problem	26	26
Wireless Communication Problem	23	23
Mechanical Problem	21	21
Radiation Output Problem	21	21
Unintended Electrical Shock	18	18
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
Device Fell	5	5
Output Problem	5	5
Temperature Problem	5	5
Operating System Becomes Nonfunctional	5	5
Computer Software Problem	4	4
Computer Operating System Problem	4	4
Component Missing	4	4
Problem with Software Installation	4	4
Failure to Align	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Transmit Record	3	3
Unintended System Motion	3	3
Premature Discharge of Battery	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	1442	1442
No Known Impact Or Consequence To Patient	532	532
Unspecified Tissue Injury	75	75
Unspecified Infection	25	25
Insufficient Information	24	24
Hemorrhage/Bleeding	24	24
Unspecified Nervous System Problem	23	23
Pain	22	22
Post Operative Wound Infection	19	19
Hematoma	17	17
Cerebrospinal Fluid Leakage	13	13
Tissue Damage	13	13
Muscle Weakness	13	13
Numbness	9	9
Nerve Damage	8	8
Urinary Retention	7	7
Thrombosis/Thrombus	6	6
Intracranial Hemorrhage	6	6
Cognitive Changes	6	6
Dysphagia/ Odynophagia	5	5
Bacterial Infection	5	5
Tissue Breakdown	5	5
Radiation Exposure, Unintended	5	5
Ambulation Difficulties	5	5
Dysphasia	5	5
No Consequences Or Impact To Patient	4	4
Spinal Column Injury	4	4
Pulmonary Emphysema	4	4
Erosion	4	4
Loss of Range of Motion	4	4
Swelling/ Edema	4	4
Confusion/ Disorientation	3	3
Bone Fracture(s)	3	3
Necrosis	3	3
Paralysis	3	3
Nicks, cuts or tears of dura or other tissues by device	3	3
Convulsion/Seizure	3	3
Nervous System Injury	3	3
Neuropathy	3	3
Dyskinesia	2	2
Cardiac Arrest	2	2
Perforation	2	2
Injury	2	2
Thrombosis	2	2
Depression	2	2
Impaired Healing	2	2
Paresis	2	2
Abscess	2	2
Paraplegia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Medical Systems, LLC	II	Jun-09-2025
2	GE OEC Medical Systems, Inc	II	Dec-18-2024
3	GE OEC Medical Systems, Inc	II	Jul-31-2023
4	GE OEC Medical Systems, Inc	II	Jul-29-2021
5	Medtronic Navigation, Inc.-Littleton	II	Jul-03-2019