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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
table, radiologic
Regulation Description
Radiologic table.
Product Code
KXJ
Regulation Number
892.1980
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
9
9
2022
50
50
2023
12
12
2024
8
8
2025
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
43
43
Fluid/Blood Leak
19
19
Positioning Failure
5
5
Loose or Intermittent Connection
4
4
Break
3
3
Insufficient Information
3
3
Device Fell
3
3
Difficult or Delayed Positioning
3
3
Use of Device Problem
2
2
Device Sensing Problem
2
2
Power Problem
2
2
Unintended System Motion
2
2
Signal Artifact/Noise
1
1
Circuit Failure
1
1
Communication or Transmission Problem
1
1
Collapse
1
1
Failure to Interrogate
1
1
Failure to Sense
1
1
Positioning Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Battery Problem
1
1
Decrease in Pressure
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Misconnection
1
1
Solder Joint Fracture
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
77
77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Insufficient Information
3
3
Laceration(s)
2
2
Pain
1
1
Muscle/Tendon Damage
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Mar-21-2025
2
Deerfield Imaging, Inc.
II
Sep-28-2021
-
-