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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, radiographic, tilting
Product CodeIXR
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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