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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 HUALUN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
2018 1647 1647
2019 1297 1297
2020 816 816
2021 554 554
2022 295 295
2023 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 1687 1687
Device Operates Differently Than Expected 471 471
Communication or Transmission Problem 438 438
Positioning Problem 345 345
Electrical /Electronic Property Problem 266 266
Failure to Run on Battery 256 256
Unexpected Shutdown 251 251
Failure to Power Up 231 231
Poor Quality Image 217 217
Noise, Audible 186 186
Imprecision 179 179
Failure to Charge 159 159
Device Displays Incorrect Message 158 158
Material Deformation 150 150
Adverse Event Without Identified Device or Use Problem 139 139
Use of Device Problem 82 82
Physical Resistance/Sticking 81 81
Application Interface Becomes Non-Functional Or Program Exits Abnormally 79 79
Mechanical Problem 77 77
Device Sensing Problem 66 66
Smoking 64 64
Image Display Error/Artifact 62 62
Device Stops Intermittently 59 59
No Display/Image 58 58
Computer Software Problem 54 54
Device Inoperable 50 50
Difficult to Open or Close 49 49
Calibration Problem 47 47
Unintended Movement 37 37
Power Problem 36 36
Application Program Problem 33 33
Arcing 27 27
Wireless Communication Problem 27 27
Break 25 25
Data Problem 19 19
Unintended Electrical Shock 16 16
Display or Visual Feedback Problem 16 16
Failure to Obtain Sample 16 16
Connection Problem 12 12
Radiation Output Failure 12 12
Failure to Fire 9 9
Failure to Advance 9 9
Premature Discharge of Battery 9 9
No Device Output 7 7
Overheating of Device 7 7
Loss of Power 6 6
Battery Problem 6 6
Unexpected/Unintended Radiation Output 6 6
Unintended Application Program Shut Down 6 6
Radiation Output Problem 6 6
Output Problem 6 6
Operating System Becomes Nonfunctional 5 5
Intermittent Loss of Power 5 5
Insufficient Information 5 5
Temperature Problem 5 5
Bent 5 5
Fracture 4 4
Component Missing 4 4
Device Fell 4 4
Failure to Shut Off 4 4
Material Twisted/Bent 3 3
Problem with Software Installation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Damaged Prior to Use 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Environmental Compatibility Problem 3 3
Material Frayed 3 3
Erratic or Intermittent Display 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Difficult to Setup or Prepare 2 2
Loose or Intermittent Connection 2 2
Radiation Leak 2 2
Device Emits Odor 2 2
Unintended Collision 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Defective Component 2 2
Failure to Align 2 2
Appropriate Term/Code Not Available 2 2
Radiation Overexposure 2 2
Mechanical Jam 2 2
Human-Device Interface Problem 2 2
Improper Device Output 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Material Integrity Problem 1 1
Protective Measures Problem 1 1
Patient Device Interaction Problem 1 1
Device Difficult to Maintain 1 1
Sharp Edges 1 1
Intermittent Communication Failure 1 1
Activation Problem 1 1
Excessive Heating 1 1
Failure to Calibrate 1 1
Device Tipped Over 1 1
Improper or Incorrect Procedure or Method 1 1
Sticking 1 1
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2600 2600
No Clinical Signs, Symptoms or Conditions 1162 1162
No Known Impact Or Consequence To Patient 941 941
No Consequences Or Impact To Patient 93 93
Unspecified Tissue Injury 41 41
Tissue Damage 18 18
Pain 16 16
Unspecified Infection 16 16
Insufficient Information 16 16
Unspecified Nervous System Problem 16 16
Radiation Exposure, Unintended 13 13
Post Operative Wound Infection 13 13
Hemorrhage/Bleeding 11 11
Muscle Weakness 11 11
Hematoma 9 9
Numbness 8 8
Iatrogenic Source 7 7
Injury 6 6
Cognitive Changes 6 6
Cerebrospinal Fluid Leakage 6 6
Urinary Retention 5 5
Spinal Column Injury 4 4
Dysphagia/ Odynophagia 4 4
Not Applicable 4 4
Thrombosis/Thrombus 4 4
Tissue Breakdown 3 3
Loss of Range of Motion 3 3
Pulmonary Emphysema 3 3
Death 3 3
Bacterial Infection 3 3
Nerve Damage 3 3
Intracranial Hemorrhage 3 3
Nervous System Injury 3 3
Cardiac Arrest 2 2
Bone Fracture(s) 2 2
Thrombosis 2 2
Therapeutic Response, Decreased 2 2
Depression 2 2
Dyskinesia 2 2
Impaired Healing 2 2
Dysphasia 2 2
Ambulation Difficulties 2 2
Electric Shock 2 2
No Information 2 2
Syncope/Fainting 1 1
Paresthesia 1 1
Foreign Body In Patient 1 1
Cardiovascular Insufficiency 1 1
Full thickness (Third Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Respiratory Tract Infection 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Complaint, Ill-Defined 1 1
Headache 1 1
Fever 1 1
Fistula 1 1
Dyspnea 1 1
Emotional Changes 1 1
Abscess 1 1
Contusion 1 1
Crushing Injury 1 1
Erosion 1 1
Radiation Burn 1 1
Burn(s) 1 1
Inflammation 1 1
Laceration(s) 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Swelling 1 1
Paralysis 1 1
Paresis 1 1
Visual Impairment 1 1
Visual Disturbances 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
4 Medtronic Navigation, Inc.-Littleton II Oct-25-2018
5 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
6 Orthoscan, Inc. II Jan-09-2018
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