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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
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORTHOSCAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
SKANRAY TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TURNER IMAGING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1697 1697
2018 1647 1647
2019 1297 1297
2020 816 816
2021 554 554
2022 295 295
2023 275 275
2024 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 1703 1703
Device Operates Differently Than Expected 1656 1656
Electrical /Electronic Property Problem 732 732
Communication or Transmission Problem 601 601
Device Displays Incorrect Message 427 427
Positioning Problem 355 355
Poor Quality Image 263 263
Unexpected Shutdown 261 261
Failure to Run on Battery 256 256
Failure to Power Up 233 233
Imprecision 197 197
Material Deformation 197 197
Noise, Audible 188 188
Computer Software Problem 181 181
Difficult to Open or Close 166 166
Adverse Event Without Identified Device or Use Problem 160 160
Failure to Charge 160 160
Device Inoperable 159 159
Application Interface Becomes Non-Functional Or Program Exits Abnormally 152 152
Mechanical Problem 150 150
Device Stops Intermittently 131 131
Calibration Problem 114 114
Display or Visual Feedback Problem 108 108
Use of Device Problem 86 86
Physical Resistance/Sticking 81 81
No Display/Image 79 79
Smoking 70 70
Device Sensing Problem 69 69
Image Display Error/Artifact 65 65
Application Program Problem 53 53
Unintended Movement 42 42
Power Problem 38 38
Break 35 35
Arcing 28 28
Wireless Communication Problem 27 27
Radiation Output Failure 26 26
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Data Problem 21 21
Unintended Electrical Shock 17 17
Failure to Advance 16 16
Failure to Obtain Sample 16 16
Device Emits Odor 16 16
Radiation Output Problem 15 15
Insufficient Information 13 13
Connection Problem 12 12
Failure to Fire 9 9
Premature Discharge of Battery 9 9
Sparking 8 8
Loss of Power 7 7
No Device Output 7 7
Overheating of Device 7 7
Fracture 6 6
Battery Problem 6 6
Output Problem 6 6
Unexpected/Unintended Radiation Output 6 6
Unintended Application Program Shut Down 6 6
Intermittent Loss of Power 5 5
Temperature Problem 5 5
Operating System Becomes Nonfunctional 5 5
Bent 5 5
Thermal Decomposition of Device 4 4
Material Frayed 4 4
Erratic or Intermittent Display 4 4
Unstable 4 4
Component Missing 4 4
Failure to Calibrate 4 4
Improper Device Output 4 4
Failure to Shut Off 4 4
Device Damaged by Another Device 4 4
Device Fell 4 4
Environmental Compatibility Problem 3 3
Material Twisted/Bent 3 3
Therapeutic or Diagnostic Output Failure 3 3
Problem with Software Installation 3 3
Device Damaged Prior to Use 3 3
Computer Operating System Problem 3 3
Device Operational Issue 2 2
Defective Component 2 2
Failure to Align 2 2
Self-Activation or Keying 2 2
Image Orientation Incorrect 2 2
Device Difficult to Setup or Prepare 2 2
Failure to Transmit Record 2 2
Unintended Collision 2 2
Unintended System Motion 2 2
Loose or Intermittent Connection 2 2
Radiation Leak 2 2
Radiation Overexposure 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Jam 2 2
Human-Device Interface Problem 2 2
Electrical Shorting 1 1
Naturally Worn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Device Difficult to Maintain 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Sharp Edges 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3709 3709
No Clinical Signs, Symptoms or Conditions 1253 1253
No Known Impact Or Consequence To Patient 1056 1056
No Consequences Or Impact To Patient 558 558
Unspecified Tissue Injury 53 53
Iatrogenic Source 25 25
Unspecified Infection 24 24
Pain 21 21
Tissue Damage 21 21
Unspecified Nervous System Problem 18 18
Insufficient Information 18 18
Hemorrhage/Bleeding 17 17
Radiation Exposure, Unintended 16 16
Post Operative Wound Infection 13 13
Muscle Weakness 12 12
Hematoma 10 10
Injury 10 10
Numbness 8 8
Cerebrospinal Fluid Leakage 8 8
Not Applicable 8 8
Nerve Damage 7 7
Spinal Column Injury 7 7
Cognitive Changes 6 6
Urinary Retention 5 5
Dysphagia/ Odynophagia 5 5
Bacterial Infection 4 4
Perforation 4 4
Loss of Range of Motion 4 4
Paralysis 4 4
Intracranial Hemorrhage 4 4
Therapeutic Response, Decreased 4 4
Dysphasia 4 4
Tissue Breakdown 4 4
Thrombosis/Thrombus 4 4
Nervous System Injury 4 4
Death 3 3
Erosion 3 3
Bone Fracture(s) 3 3
Pulmonary Emphysema 3 3
Cardiac Arrest 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Depression 2 2
Dyskinesia 2 2
Impaired Healing 2 2
Necrosis 2 2
Thrombosis 2 2
Swelling/ Edema 2 2
No Information 2 2
No Code Available 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Cardiovascular Insufficiency 1 1
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Rupture 1 1
Visual Impairment 1 1
Visual Disturbances 1 1
Vomiting 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Respiratory Tract Infection 1 1
Paraplegia 1 1
Respiratory Failure 1 1
Skin Tears 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Full thickness (Third Degree) Burn 1 1
Abscess 1 1
Contusion 1 1
Crushing Injury 1 1
Radiation Burn 1 1
Burn(s) 1 1
Erythema 1 1
Fever 1 1
Fistula 1 1
Headache 1 1
Dyspnea 1 1
Emotional Changes 1 1
Myocardial Infarction 1 1
Inflammation 1 1
Laceration(s) 1 1
Paresis 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Swelling 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 GE OEC Medical Systems, Inc II Feb-27-2017
4 GE OEC Medical Systems, Inc II Jan-09-2017
5 Medtronic Navigation, Inc.-Littleton II Jul-03-2019
6 Medtronic Navigation, Inc.-Littleton II Oct-25-2018
7 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
8 Orthoscan, Inc. II Jan-09-2018
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