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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 3
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 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 1476 1476
Positioning Problem 305 305
Communication or Transmission Problem 266 266
Unexpected Shutdown 244 244
Failure to Run on Battery 201 201
Failure to Power Up 186 186
Noise, Audible 171 171
Imprecision 154 154
Poor Quality Image 147 147
Failure to Charge 142 142
Adverse Event Without Identified Device or Use Problem 133 133
Material Deformation 104 104
Physical Resistance/Sticking 74 74
Use of Device Problem 67 67
Smoking 65 65
Device Sensing Problem 64 64
Image Display Error/Artifact 56 56
Power Problem 32 32
Unintended Movement 31 31
No Display/Image 27 27
Arcing 27 27
Calibration Problem 26 26
Application Program Problem 23 23
Radiation Output Failure 23 23
Wireless Communication Problem 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Unintended Electrical Shock 17 17
Failure to Advance 16 16
Radiation Output Problem 14 14
Data Problem 13 13
Connection Problem 11 11
Mechanical 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
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 1238 1238
No Known Impact Or Consequence To Patient 532 532
Unspecified Tissue Injury 52 52
Unspecified Infection 22 22
Insufficient Information 18 18
Unspecified Nervous System Problem 18 18
Pain 16 16
Hemorrhage/Bleeding 15 15
Tissue Damage 13 13
Post Operative Wound Infection 13 13
Muscle Weakness 12 12
Hematoma 10 10
Cerebrospinal Fluid Leakage 8 8
Numbness 8 8
Cognitive Changes 6 6
Radiation Exposure, Unintended 5 5
Dysphagia/ Odynophagia 5 5
Urinary Retention 5 5
Nerve Damage 5 5
Spinal Column Injury 4 4
Bacterial Infection 4 4
Intracranial Hemorrhage 4 4
Tissue Breakdown 4 4
Thrombosis/Thrombus 4 4
Dysphasia 4 4
No Consequences Or Impact To Patient 4 4
Loss of Range of Motion 3 3
Nervous System Injury 3 3
Pulmonary Emphysema 3 3
Bone Fracture(s) 3 3
Erosion 3 3
Paralysis 3 3
Necrosis 2 2
Cardiac Arrest 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Thrombosis 2 2
Injury 2 2
Depression 2 2
Dyskinesia 2 2
Impaired Healing 2 2
Swelling/ Edema 2 2
Rupture 1 1
Discomfort 1 1
Respiratory Tract Infection 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Electric Shock 1 1
Foreign Body In Patient 1 1
No Information 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Cardiovascular Insufficiency 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Abscess 1 1
Burn(s) 1 1
Dyspnea 1 1
Emotional Changes 1 1
Crushing Injury 1 1
Death 1 1
Headache 1 1
Fever 1 1
Fistula 1 1
Inflammation 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Paresis 1 1
Perforation 1 1
Swelling 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 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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