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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
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 Displays Incorrect Message 8 8
Unintended Movement 7 7
No Display/Image 6 6
Self-Activation or Keying 3 3
Loss of Power 2 2
Mechanical Problem 2 2
Smoking 2 2
Failure to Align 2 2
Sticking 1 1
Device Stops Intermittently 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Calibrate 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Loss of Data 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Failure to Shut Off 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Optical Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Radiation Overexposure 1 1
Moisture Damage 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
Difficult To Position 1 1
Failure to Transmit Record 1 1
Failure to Read Input Signal 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Leak/Splash 1 1
Device Alarm System 1 1
Thermal Decomposition of Device 1 1
Corroded 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Positioning Failure 1 1
Disconnection 1 1
Erratic or Intermittent Display 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 10 10
No Clinical Signs, Symptoms or Conditions 6 6
No Information 4 4
Insufficient Information 4 4
No Patient Involvement 3 3
Radiation Exposure, Unintended 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
2 Oakworks Inc II May-23-2019
3 Oakworks Inc II Feb-23-2018
4 Philips Medical Systems Nederlands II May-03-2018
5 Philips North America, LLC II Mar-13-2020
6 Philips North America, LLC II Mar-23-2019
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