TPLC - Total Product Life Cycle

show TPLC since

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	1504	1504
Positioning Problem	306	306
Communication or Transmission Problem	268	268
Unexpected Shutdown	255	255
Failure to Run on Battery	201	201
Failure to Power Up	190	190
Noise, Audible	178	178
Imprecision	154	154
Adverse Event Without Identified Device or Use Problem	149	149
Poor Quality Image	148	148
Failure to Charge	146	146
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	58	58
Radiation Output Failure	56	56
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
Display or Visual Feedback Problem	3	3
Device Displays Incorrect Message	3	3
Failure to Shut Off	3	3
Battery 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	1345	1345
No Known Impact Or Consequence To Patient	532	532
Unspecified Tissue Injury	69	69
Unspecified Infection	22	22
Pain	20	20
Unspecified Nervous System Problem	20	20
Insufficient Information	19	19
Hemorrhage/Bleeding	18	18
Post Operative Wound Infection	18	18
Tissue Damage	13	13
Muscle Weakness	13	13
Hematoma	12	12
Cerebrospinal Fluid Leakage	11	11
Numbness	9	9
Nerve Damage	8	8
Cognitive Changes	6	6
Dysphasia	5	5
Radiation Exposure, Unintended	5	5
Bacterial Infection	5	5
Dysphagia/ Odynophagia	5	5
Urinary Retention	5	5
Thrombosis/Thrombus	5	5
Loss of Range of Motion	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
Pulmonary Emphysema	3	3
Bone Fracture(s)	3	3
Paralysis	3	3
Ambulation Difficulties	2	2
Convulsion/Seizure	2	2
Dyspnea	2	2
Depression	2	2
Thrombosis	2	2
Neuropathy	2	2
Injury	2	2
Impaired Healing	2	2
Confusion/ Disorientation	2	2
Cardiac Arrest	2	2
Necrosis	2	2
Dyskinesia	2	2
Perforation	2	2
Unintended Radiation Exposure	1	1
Fistula	1	1
Respiratory Failure	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