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TPLC
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show TPLC since
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Device
table, radiographic, tilting
Product Code
IXR
Regulation Number
892.1980
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
120
120
2015
82
82
2016
58
58
2017
25
25
2018
17
17
2019
8
8
2020
12
12
2021
5
5
2022
2
2
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
143
143
Device Displays Incorrect Message
32
32
Device Inoperable
30
30
No Display/Image
25
25
Unintended Movement
24
24
Mechanical Problem
18
18
Loss of Power
10
10
Detachment Of Device Component
9
9
Computer Operating System Problem
9
9
Failure to Align
7
7
Self-Activation or Keying
7
7
Positioning Problem
7
7
Poor Quality Image
5
5
Failure to Power Up
4
4
Component Falling
4
4
Noise, Audible
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Device Operational Issue
3
3
Difficult to Open or Close
3
3
Communication or Transmission Problem
3
3
Smoking
3
3
Sticking
3
3
Device Stops Intermittently
3
3
Application Interface Becomes Non-Functional Or Program Exits Abnormally
3
3
Output Problem
3
3
Circuit Failure
2
2
Device Remains Activated
2
2
Unintended Collision
2
2
Unintended System Motion
2
2
No Device Output
2
2
Overheating of Device
2
2
Difficult To Position
2
2
Failure to Shut Off
2
2
Improper Device Output
2
2
Mechanical Jam
2
2
Detachment of Device or Device Component
2
2
Optical Problem
2
2
Programming Issue
2
2
Radiation Overexposure
1
1
Power Problem
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Insufficient Information
1
1
Operating System Becomes Nonfunctional
1
1
Mechanics Altered
1
1
Malposition of Device
1
1
Application Program Problem
1
1
Loss of Data
1
1
Inadequate Service
1
1
Failure to Read Input Signal
1
1
Device Slipped
1
1
Unstable
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Calibrate
1
1
High Test Results
1
1
High Readings
1
1
Moisture Damage
1
1
Device Alarm System
1
1
Thermal Decomposition of Device
1
1
Device Emits Odor
1
1
Unable to Obtain Readings
1
1
Failure to Transmit Record
1
1
Positioning Failure
1
1
Disconnection
1
1
Erratic or Intermittent Display
1
1
Computer Software Problem
1
1
Corroded
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Entrapment of Device
1
1
Fire
1
1
Fluid/Blood Leak
1
1
Excess Flow or Over-Infusion
1
1
Leak/Splash
1
1
Device Maintenance Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
147
147
No Known Impact Or Consequence To Patient
143
143
No Patient Involvement
14
14
No Information
10
10
No Clinical Signs, Symptoms or Conditions
6
6
Insufficient Information
4
4
Not Applicable
2
2
Injury
2
2
Neck Pain
1
1
Complaint, Ill-Defined
1
1
Fall
1
1
Head Injury
1
1
Pain
1
1
Thrombosis
1
1
Radiation Exposure, Unintended
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare, LLC
II
May-22-2017
2
GE Healthcare, LLC
II
Dec-23-2016
3
LIEBEL-FLARSHEIM COMPANY LLC
II
Aug-21-2018
4
Medical Positioning Inc
II
Apr-13-2011
5
Oakworks Inc
II
May-23-2019
6
Oakworks Inc
II
Feb-23-2018
7
Philips Electronics North America Corporation
II
Aug-01-2016
8
Philips Healthcare Inc.
II
Aug-15-2012
9
Philips Healthcare Inc.
II
Jun-18-2012
10
Philips Medical Systems Nederlands
II
May-03-2018
11
Philips Medical Systems North America Co. Phillips
II
Sep-13-2010
12
Philips Medical Systems North America Co. Phillips
II
Mar-23-2010
13
Philips North America, LLC
II
Mar-13-2020
14
Philips North America, LLC
II
Mar-23-2019
15
Shimadzu Medical Systems
II
Apr-28-2016
16
Toshiba American Medical Systems Inc
II
Mar-16-2011
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