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Device
image-intensified fluoroscopic x-ray system, mobile
Definition
Fluoroscopy of the human body.
Product Code
OXO
Regulation Number
892.1650
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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