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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device image-intensified fluoroscopic x-ray system, mobile
Definition Fluoroscopy of the human body.
Product CodeOXO
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSCAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
TURNER IMAGING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1297 1297
2020 816 816
2021 554 554
2022 295 295
2023 275 275
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 1473 1473
Positioning Problem 305 305
Communication or Transmission Problem 266 266
Unexpected Shutdown 241 241
Failure to Run on Battery 201 201
Failure to Power Up 186 186
Noise, Audible 170 170
Imprecision 154 154
Poor Quality Image 144 144
Failure to Charge 142 142
Adverse Event Without Identified Device or Use Problem 128 128
Material Deformation 104 104
Physical Resistance/Sticking 74 74
Use of Device Problem 67 67
Device Sensing Problem 64 64
Smoking 60 60
Image Display Error/Artifact 56 56
Power Problem 32 32
Unintended Movement 31 31
Arcing 27 27
No Display/Image 26 26
Calibration Problem 26 26
Wireless Communication Problem 22 22
Application Program Problem 20 20
Radiation Output Failure 20 20
Unintended Electrical Shock 16 16
Failure to Advance 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Data Problem 12 12
Radiation Output Problem 12 12
Connection Problem 11 11
Mechanical Problem 10 10
Electrical /Electronic Property Problem 9 9
Overheating of Device 7 7
Unexpected/Unintended Radiation Output 6 6
Operating System Becomes Nonfunctional 5 5
Temperature Problem 5 5
Device Fell 4 4
Output Problem 4 4
Component Missing 4 4
Failure to Shut Off 3 3
Computer Operating System Problem 3 3
Device Displays Incorrect Message 3 3
Therapeutic or Diagnostic Output Failure 3 3
Problem with Software Installation 3 3
Appropriate Term/Code Not Available 2 2
Battery Problem 2 2
Environmental Compatibility Problem 2 2
Failure to Align 2 2
Device Damaged Prior to Use 2 2
Loss of Power 2 2
Failure to Transmit Record 2 2
Fracture 2 2
Display or Visual Feedback Problem 2 2
Computer Software Problem 2 2
Unintended Collision 2 2
Unintended System Motion 1 1
No Device Output 1 1
Image Orientation Incorrect 1 1
Radiation Leak 1 1
Positioning Failure 1 1
Complete Blockage 1 1
Self-Activation or Keying 1 1
Device Tipped Over 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Protective Measures Problem 1 1
Radiation Overexposure 1 1
Device Difficult to Maintain 1 1
Excessive Heating 1 1
Delayed Program or Algorithm Execution 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1466 1466
No Clinical Signs, Symptoms or Conditions 1210 1210
No Known Impact Or Consequence To Patient 532 532
Unspecified Tissue Injury 47 47
Unspecified Nervous System Problem 18 18
Insufficient Information 17 17
Unspecified Infection 17 17
Pain 16 16
Tissue Damage 13 13
Post Operative Wound Infection 13 13
Muscle Weakness 11 11
Hemorrhage/Bleeding 11 11
Hematoma 10 10
Numbness 8 8
Cerebrospinal Fluid Leakage 7 7
Cognitive Changes 6 6
Radiation Exposure, Unintended 5 5
Urinary Retention 5 5
Spinal Column Injury 4 4
Nerve Damage 4 4
Dysphagia/ Odynophagia 4 4
Intracranial Hemorrhage 4 4
Thrombosis/Thrombus 4 4
Tissue Breakdown 4 4
No Consequences Or Impact To Patient 4 4
Nervous System Injury 3 3
Pulmonary Emphysema 3 3
Bacterial Infection 3 3
Loss of Range of Motion 3 3
Dysphasia 3 3
Thrombosis 2 2
Paralysis 2 2
Cardiac Arrest 2 2
Bone Fracture(s) 2 2
Ambulation Difficulties 2 2
Swelling/ Edema 2 2
Injury 2 2
Depression 2 2
Dyskinesia 2 2
Impaired Healing 2 2
Discomfort 1 1
Respiratory Tract Infection 1 1
Foreign Body In Patient 1 1
Electric Shock 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Cardiovascular Insufficiency 1 1
No Information 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Headache 1 1
Fever 1 1
Fistula 1 1
Inflammation 1 1
Laceration(s) 1 1
Abscess 1 1
Erosion 1 1
Burn(s) 1 1
Dyspnea 1 1
Emotional Changes 1 1
Crushing Injury 1 1
Death 1 1
Paresis 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Swelling 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Vomiting 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
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