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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2007
2008
2009
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2012
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2014
2015
2016
2017
2018
2019
2020
2021
2022
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Device
table, radiographic, tilting
Product Code
IXR
Regulation Number
892.1980
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
25
25
2018
17
17
2019
8
8
2020
12
12
2021
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
20
20
No Display/Image
9
9
Device Displays Incorrect Message
9
9
Self-Activation or Keying
4
4
Device Operates Differently Than Expected
4
4
Device Operational Issue
2
2
Failure to Shut Off
2
2
Optical Problem
2
2
Noise, Audible
2
2
Failure to Align
2
2
Smoking
2
2
Loss of Power
2
2
Failure to Power Up
2
2
Computer Operating System Problem
2
2
Device Stops Intermittently
2
2
Mechanical Problem
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Positioning Failure
1
1
Disconnection
1
1
Erratic or Intermittent Display
1
1
Device Alarm System
1
1
Thermal Decomposition of Device
1
1
Circuit Failure
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Corroded
1
1
Moisture Damage
1
1
Unintended Collision
1
1
Unintended System Motion
1
1
Difficult To Position
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Fluid Leak
1
1
Leak/Splash
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Calibrate
1
1
Loss of Data
1
1
Communication or Transmission Problem
1
1
Unable to Obtain Readings
1
1
Failure to Transmit Record
1
1
Sticking
1
1
Failure to Read Input Signal
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Insufficient Information
1
1
Output Problem
1
1
Positioning Problem
1
1
Radiation Overexposure
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
33
33
No Consequences Or Impact To Patient
14
14
No Patient Involvement
8
8
No Information
5
5
Insufficient Information
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Radiation Exposure, Unintended
1
1
Not Applicable
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare, LLC
II
May-22-2017
2
LIEBEL-FLARSHEIM COMPANY LLC
II
Aug-21-2018
3
Oakworks Inc
II
May-23-2019
4
Oakworks Inc
II
Feb-23-2018
5
Philips Medical Systems Nederlands
II
May-03-2018
6
Philips North America, LLC
II
Mar-13-2020
7
Philips North America, LLC
II
Mar-23-2019
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