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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 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 1481 1481
Positioning Problem 305 305
Communication or Transmission Problem 266 266
Unexpected Shutdown 250 250
Failure to Run on Battery 201 201
Failure to Power Up 188 188
Noise, Audible 173 173
Imprecision 154 154
Poor Quality Image 148 148
Failure to Charge 144 144
Adverse Event Without Identified Device or Use Problem 141 141
Material Deformation 104 104
Physical Resistance/Sticking 74 74
Use of Device Problem 68 68
Smoking 65 65
Device Sensing Problem 64 64
Image Display Error/Artifact 57 57
Power Problem 33 33
Radiation Output Failure 32 32
Unintended Movement 31 31
Incorrect, Inadequate or Imprecise Result or Readings 30 30
No Display/Image 29 29
Arcing 28 28
Application Program Problem 28 28
Calibration Problem 26 26
Wireless Communication Problem 22 22
Failure to Advance 21 21
Unintended Electrical Shock 17 17
Radiation Output Problem 16 16
Data Problem 14 14
Mechanical Problem 12 12
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
Temperature Problem 5 5
Device Fell 4 4
Output Problem 4 4
Component Missing 4 4
Failure to Align 3 3
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
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 1271 1271
No Known Impact Or Consequence To Patient 532 532
Unspecified Tissue Injury 62 62
Unspecified Infection 22 22
Pain 20 20
Unspecified Nervous System Problem 19 19
Insufficient Information 19 19
Hemorrhage/Bleeding 16 16
Post Operative Wound Infection 15 15
Tissue Damage 13 13
Muscle Weakness 12 12
Hematoma 11 11
Cerebrospinal Fluid Leakage 9 9
Nerve Damage 8 8
Numbness 8 8
Cognitive Changes 6 6
Thrombosis/Thrombus 5 5
Radiation Exposure, Unintended 5 5
Urinary Retention 5 5
Loss of Range of Motion 5 5
Dysphagia/ Odynophagia 5 5
Bacterial Infection 5 5
Intracranial Hemorrhage 4 4
Spinal Column Injury 4 4
Dysphasia 4 4
No Consequences Or Impact To Patient 4 4
Tissue Breakdown 4 4
Swelling/ Edema 4 4
Nervous System Injury 3 3
Paralysis 3 3
Bone Fracture(s) 3 3
Pulmonary Emphysema 3 3
Erosion 3 3
Cardiac Arrest 2 2
Dyspnea 2 2
Neuropathy 2 2
Thrombosis 2 2
Necrosis 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Injury 2 2
Depression 2 2
Dyskinesia 2 2
Impaired Healing 2 2
Paraplegia 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Rupture 1 1
Discomfort 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Vomiting 1 1
Electric Shock 1 1
Respiratory Tract Infection 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
Unintended Radiation Exposure 1 1
Neurological Deficit/Dysfunction 1 1
Myocardial Infarction 1 1
Inflammation 1 1
Laceration(s) 1 1
Swelling 1 1
Paresis 1 1
Perforation 1 1
Emotional Changes 1 1
Crushing Injury 1 1
Death 1 1
Abscess 1 1
Burn(s) 1 1
Erythema 1 1
Fever 1 1
Fistula 1 1
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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