Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
1. K190024
Smart-C
MDR Year
MDR Reports
MDR Events
2019
1297
1297
2020
816
816
2021
554
554
2022
295
295
2023
275
275
2024
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Application Program Freezes, Becomes Nonfunctional
1476
1476
Positioning Problem
305
305
Communication or Transmission Problem
266
266
Unexpected Shutdown
244
244
Failure to Run on Battery
201
201
Failure to Power Up
186
186
Noise, Audible
171
171
Imprecision
154
154
Poor Quality Image
147
147
Failure to Charge
142
142
Adverse Event Without Identified Device or Use Problem
133
133
Material Deformation
104
104
Physical Resistance/Sticking
74
74
Use of Device Problem
67
67
Smoking
65
65
Device Sensing Problem
64
64
Image Display Error/Artifact
56
56
Power Problem
32
32
Unintended Movement
31
31
No Display/Image
27
27
Arcing
27
27
Calibration Problem
26
26
Application Program Problem
23
23
Radiation Output Failure
23
23
Wireless Communication Problem
22
22
Incorrect, Inadequate or Imprecise Result or Readings
22
22
Unintended Electrical Shock
17
17
Failure to Advance
16
16
Radiation Output Problem
14
14
Data Problem
13
13
Connection Problem
11
11
Mechanical 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 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
Failure to Align
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
1238
1238
No Known Impact Or Consequence To Patient
532
532
Unspecified Tissue Injury
52
52
Unspecified Infection
22
22
Insufficient Information
18
18
Unspecified Nervous System Problem
18
18
Pain
16
16
Hemorrhage/Bleeding
15
15
Tissue Damage
13
13
Post Operative Wound Infection
13
13
Muscle Weakness
12
12
Hematoma
10
10
Cerebrospinal Fluid Leakage
8
8
Numbness
8
8
Cognitive Changes
6
6
Radiation Exposure, Unintended
5
5
Dysphagia/ Odynophagia
5
5
Urinary Retention
5
5
Nerve Damage
5
5
Spinal Column Injury
4
4
Bacterial Infection
4
4
Intracranial Hemorrhage
4
4
Tissue Breakdown
4
4
Thrombosis/Thrombus
4
4
Dysphasia
4
4
No Consequences Or Impact To Patient
4
4
Loss of Range of Motion
3
3
Nervous System Injury
3
3
Pulmonary Emphysema
3
3
Bone Fracture(s)
3
3
Erosion
3
3
Paralysis
3
3
Necrosis
2
2
Cardiac Arrest
2
2
Ambulation Difficulties
2
2
Confusion/ Disorientation
2
2
Thrombosis
2
2
Injury
2
2
Depression
2
2
Dyskinesia
2
2
Impaired Healing
2
2
Swelling/ Edema
2
2
Rupture
1
1
Discomfort
1
1
Respiratory Tract Infection
1
1
Paraplegia
1
1
Respiratory Failure
1
1
Skin Tears
1
1
Electric Shock
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unintended Radiation Exposure
1
1
Abscess
1
1
Burn(s)
1
1
Dyspnea
1
1
Emotional Changes
1
1
Crushing Injury
1
1
Death
1
1
Headache
1
1
Fever
1
1
Fistula
1
1
Inflammation
1
1
Laceration(s)
1
1
Myocardial Infarction
1
1
Paresis
1
1
Perforation
1
1
Swelling
1
1
Neurological Deficit/Dysfunction
1
1
Neuropathy
1
1
Visual Impairment
1
1
Visual Disturbances
1
1
Vomiting
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
-
-