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TPLC
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Device
table, radiographic, tilting
Regulation Description
Radiologic table.
Product Code
IXR
Regulation Number
892.1980
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
8
8
2020
12
12
2021
5
5
2022
2
2
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
5
5
No Display/Image
4
4
Device Displays Incorrect Message
4
4
Smoking
2
2
Self-Activation or Keying
2
2
Disconnection
1
1
Leak/Splash
1
1
Failure to Read Input Signal
1
1
Failure to Shut Off
1
1
Mechanical Problem
1
1
Communication or Transmission Problem
1
1
Device Operational Issue
1
1
Insufficient Information
1
1
Failure to Transmit Record
1
1
Positioning Failure
1
1
Failure to Align
1
1
Thermal Decomposition of Device
1
1
Mechanics Altered
1
1
Optical Problem
1
1
Detachment of Device or Device Component
1
1
Erratic or Intermittent Display
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Loss of Data
1
1
Mechanical Jam
1
1
Inadequate User Interface
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7
7
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
5
5
Insufficient Information
4
4
No Patient Involvement
3
3
Radiation Exposure, Unintended
1
1
No Information
1
1
Crushing Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Oakworks Inc
II
May-23-2019
2
Philips North America, LLC
II
Mar-13-2020
3
Philips North America, LLC
II
Mar-23-2019
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