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
1. K192819 OEC Elite
2. K203346 OEC 3D
3. K233669 OEC 3D
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	1525	1525
Positioning Problem	307	307
Communication or Transmission Problem	270	270
Unexpected Shutdown	255	255
Failure to Run on Battery	202	202
Failure to Power Up	190	190
Noise, Audible	182	182
Adverse Event Without Identified Device or Use Problem	158	158
Imprecision	154	154
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	64	64
Image Display Error/Artifact	58	58
Incorrect, Inadequate or Imprecise Result or Readings	46	46
Application Program Problem	38	38
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
Temperature Problem	5	5
Operating System Becomes Nonfunctional	5	5
Output Problem	5	5
Device Fell	4	4
Component Missing	4	4
Problem with Software Installation	4	4
Computer Operating System Problem	4	4
Unintended System Motion	3	3
Failure to Shut Off	3	3
Device Displays Incorrect Message	3	3
Therapeutic or Diagnostic Output Failure	3	3
Computer Software Problem	3	3
Failure to Align	3	3
Failure to Transmit Record	3	3
Display or Visual Feedback Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	1466	1466
No Clinical Signs, Symptoms or Conditions	1376	1376
No Known Impact Or Consequence To Patient	532	532
Unspecified Tissue Injury	70	70
Unspecified Infection	23	23
Unspecified Nervous System Problem	21	21
Pain	21	21
Post Operative Wound Infection	20	20
Hemorrhage/Bleeding	19	19
Insufficient Information	19	19
Hematoma	13	13
Muscle Weakness	13	13
Tissue Damage	13	13
Cerebrospinal Fluid Leakage	13	13
Numbness	9	9
Nerve Damage	8	8
Thrombosis/Thrombus	6	6
Cognitive Changes	6	6
Urinary Retention	6	6
Tissue Breakdown	5	5
Loss of Range of Motion	5	5
Dysphagia/ Odynophagia	5	5
Bacterial Infection	5	5
Radiation Exposure, Unintended	5	5
Intracranial Hemorrhage	5	5
Dysphasia	5	5
Swelling/ Edema	4	4
No Consequences Or Impact To Patient	4	4
Pulmonary Emphysema	4	4
Spinal Column Injury	4	4
Confusion/ Disorientation	3	3
Paralysis	3	3
Convulsion/Seizure	3	3
Ambulation Difficulties	3	3
Nervous System Injury	3	3
Neuropathy	3	3
Erosion	3	3
Bone Fracture(s)	3	3
Cardiac Arrest	2	2
Dyspnea	2	2
Perforation	2	2
Necrosis	2	2
Depression	2	2
Paresis	2	2
Impaired Healing	2	2
Thrombosis	2	2
Dyskinesia	2	2
Injury	2	2
Death	1	1
Fever	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