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TPLC
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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
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
146
146
Device Problems
MDRs with this Device Problem
Events in those MDRs
Application Program Freezes, Becomes Nonfunctional
1492
1492
Positioning Problem
305
305
Communication or Transmission Problem
267
267
Unexpected Shutdown
255
255
Failure to Run on Battery
201
201
Failure to Power Up
190
190
Noise, Audible
175
175
Imprecision
154
154
Poor Quality Image
148
148
Adverse Event Without Identified Device or Use Problem
147
147
Failure to Charge
145
145
Material Deformation
105
105
Physical Resistance/Sticking
75
75
Use of Device Problem
69
69
Smoking
65
65
Device Sensing Problem
64
64
Image Display Error/Artifact
57
57
Radiation Output Failure
45
45
Application Program Problem
34
34
Incorrect, Inadequate or Imprecise Result or Readings
33
33
Power Problem
33
33
Unintended Movement
31
31
No Display/Image
29
29
Arcing
28
28
Calibration Problem
26
26
Failure to Advance
26
26
Wireless Communication Problem
22
22
Radiation Output Problem
18
18
Unintended Electrical Shock
17
17
Data Problem
14
14
Mechanical Problem
13
13
Connection Problem
11
11
Electrical /Electronic Property Problem
9
9
Overheating of Device
7
7
Unexpected/Unintended Radiation Output
6
6
Temperature Problem
5
5
Operating System Becomes Nonfunctional
5
5
Device Fell
4
4
Component Missing
4
4
Computer Operating System Problem
4
4
Output Problem
4
4
Problem with Software Installation
3
3
Therapeutic or Diagnostic Output Failure
3
3
Failure to Transmit Record
3
3
Device Displays Incorrect Message
3
3
Failure to Align
3
3
Failure to Shut Off
3
3
Device Damaged Prior to Use
2
2
Fracture
2
2
Appropriate Term/Code Not Available
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
1466
1466
No Clinical Signs, Symptoms or Conditions
1309
1309
No Known Impact Or Consequence To Patient
532
532
Unspecified Tissue Injury
67
67
Unspecified Infection
22
22
Pain
20
20
Unspecified Nervous System Problem
20
20
Insufficient Information
19
19
Hemorrhage/Bleeding
17
17
Post Operative Wound Infection
17
17
Muscle Weakness
13
13
Tissue Damage
13
13
Hematoma
12
12
Cerebrospinal Fluid Leakage
11
11
Numbness
9
9
Nerve Damage
8
8
Cognitive Changes
6
6
Dysphasia
5
5
Bacterial Infection
5
5
Radiation Exposure, Unintended
5
5
Dysphagia/ Odynophagia
5
5
Loss of Range of Motion
5
5
Urinary Retention
5
5
Thrombosis/Thrombus
5
5
Tissue Breakdown
4
4
No Consequences Or Impact To Patient
4
4
Swelling/ Edema
4
4
Spinal Column Injury
4
4
Intracranial Hemorrhage
4
4
Nervous System Injury
3
3
Erosion
3
3
Bone Fracture(s)
3
3
Pulmonary Emphysema
3
3
Paralysis
3
3
Ambulation Difficulties
2
2
Convulsion/Seizure
2
2
Dyspnea
2
2
Depression
2
2
Thrombosis
2
2
Injury
2
2
Confusion/ Disorientation
2
2
Cardiac Arrest
2
2
Dyskinesia
2
2
Perforation
2
2
Necrosis
2
2
Neuropathy
2
2
Impaired Healing
2
2
Fever
1
1
Visual Disturbances
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
Medtronic Navigation, Inc.-Littleton
II
Jul-03-2019
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