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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	1492	1492
Positioning Problem	305	305
Communication or Transmission Problem	267	267
Unexpected Shutdown	255	255
Failure to Run on Battery	201	201
Failure to Power Up	190	190
Noise, Audible	175	175
Imprecision	154	154
Poor Quality Image	148	148
Adverse Event Without Identified Device or Use Problem	147	147
Failure to Charge	145	145
Material Deformation	105	105
Physical Resistance/Sticking	75	75
Use of Device Problem	69	69
Smoking	65	65
Device Sensing Problem	64	64
Image Display Error/Artifact	57	57
Radiation Output Failure	45	45
Application Program Problem	34	34
Power Problem	33	33
Incorrect, Inadequate or Imprecise Result or Readings	33	33
Unintended Movement	31	31
No Display/Image	29	29
Arcing	28	28
Calibration Problem	26	26
Failure to Advance	26	26
Wireless Communication Problem	22	22
Radiation Output Problem	18	18
Unintended Electrical Shock	17	17
Data Problem	14	14
Mechanical Problem	13	13
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
Device Fell	4	4
Computer Operating System Problem	4	4
Component Missing	4	4
Output Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Failure to Transmit Record	3	3
Problem with Software Installation	3	3
Failure to Align	3	3
Failure to Shut Off	3	3
Device Displays Incorrect Message	3	3
Device Damaged Prior to Use	2	2
Appropriate Term/Code Not Available	2	2
Computer Software Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	1466	1466
No Clinical Signs, Symptoms or Conditions	1309	1309
No Known Impact Or Consequence To Patient	532	532
Unspecified Tissue Injury	67	67
Unspecified Infection	22	22
Pain	20	20
Unspecified Nervous System Problem	20	20
Insufficient Information	19	19
Hemorrhage/Bleeding	17	17
Post Operative Wound Infection	17	17
Muscle Weakness	13	13
Tissue Damage	13	13
Hematoma	12	12
Cerebrospinal Fluid Leakage	11	11
Numbness	9	9
Nerve Damage	8	8
Cognitive Changes	6	6
Dysphasia	5	5
Bacterial Infection	5	5
Radiation Exposure, Unintended	5	5
Dysphagia/ Odynophagia	5	5
Loss of Range of Motion	5	5
Urinary Retention	5	5
Thrombosis/Thrombus	5	5
Tissue Breakdown	4	4
No Consequences Or Impact To Patient	4	4
Swelling/ Edema	4	4
Spinal Column Injury	4	4
Intracranial Hemorrhage	4	4
Nervous System Injury	3	3
Erosion	3	3
Bone Fracture(s)	3	3
Pulmonary Emphysema	3	3
Paralysis	3	3
Ambulation Difficulties	2	2
Convulsion/Seizure	2	2
Dyspnea	2	2
Depression	2	2
Thrombosis	2	2
Injury	2	2
Confusion/ Disorientation	2	2
Cardiac Arrest	2	2
Dyskinesia	2	2
Perforation	2	2
Necrosis	2	2
Neuropathy	2	2
Impaired Healing	2	2
Fever	1	1
Visual Disturbances	1	1
Swelling	1	1

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